Cardiogenic ShockNCT07062744
The Role of Swan-Ganz Catheter in Hemodynamic Resuscitation for Patients With Cardiogenic Shock
A study testing Swan-Ganz IQ Pulmonary Arterial catheter and Swan-Ganz IQ catheter in people with Cardiogenic Shock and Pulmonary Artery Catheter Waveform Interpretation, run by Bach Mai Hospital at 1 site in Vietnam.
Trial summary
This clinical trial examines whether the use of the Swan-Ganz catheter, a specialized pulmonary artery catheter, can improve hemodynamic management and treatment outcomes in patients experiencing cardiogenic shock due to acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Pulmonary Artery Catheter Waveform Interpretation, Hemodynamic Management
- What is being tested?
- Swan-Ganz IQ Pulmonary Arterial catheter and Swan-Ganz IQ catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteVietnam
- Study dates
- 27 May 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Provided written informed consent to participate in the study.
- Diagnosed with cardiogenic shock due to acute myocardial infarction according to IABP-SHOCK II (2012) criteria:
- Systolic blood pressure (SBP) < 90 mmHg for at least 30 minutes, or requiring vasopressor agents to maintain SBP > 90 mmHg.
- Evidence of end-organ hypoperfusion, indicated by at least one of the following: Altered mental status, Urine output < 30 mL/hour, Cold extremities with mottled skin, Serum lactate level > 2 mmol/L.
Who cannot join
- Presence of cervical cellulitis.
- Inability to identify neck anatomy or history of cervical radiotherapy.
- Coagulopathy (INR > 1.5 and/or platelet count < 50 G/L).
- End-stage chronic diseases, including: Advanced malignancy, advanced-stage HIV, bedridden patients for more than 3 months, decompensated liver cirrhosis (Child-Pugh class C).
- Patients with cardiac arrest or mechanical complications such as myocardial rupture prior to Swan-Ganz catheterization.
- Congenital heart defects or intracardiac shunts. Refusal of participation by the patient or their legal representative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
BachMai Hospital, Hanoi Medical University
Hanoi, 100000
Thang Pham, MD, PhD Candidate, 0357991992, pxthanghmu92@gmail.com
About this study
This clinical trial examines whether the use of the Swan-Ganz catheter, a specialized pulmonary artery catheter, can improve hemodynamic management and treatment outcomes in patients experiencing cardiogenic shock due to acute myocardial infarction (AMI).
Cardiogenic shock is a critical condition marked by the heart's inability to supply adequate blood to the organs, often resulting from a severe heart attack. Despite advancements in care, the condition remains associated with high mortality. Effective monitoring of cardiovascular status is crucial in guiding timely and tailored treatment decisions.
Read more
Participants in this study will undergo advanced hemodynamic monitoring using the Swan-Ganz catheter, which provides continuous data on cardiac output and other key parameters. This information enables physicians to better assess circulatory function and adjust therapies accordingly.
The research will evaluate clinical characteristics, response to treatment, and 30-day outcomes in patients managed with this technique. The study also aims to identify factors associated with successful hemodynamic stabilization and potential complications related to catheter use.
A total of 108 adult patients meeting specific eligibility criteria will be enrolled at Bach Mai Hospital over 3 years. Participation is voluntary, and all patients will continue to receive standard-of-care treatment. All personal and medical data will be handled with strict confidentiality.
Read the detailed description
This is a clinical trial without a control group; a single-center study evaluates goal-directed hemodynamic optimization using pulmonary artery catheterization (Swan-Ganz catheter) in adult patients with cardiogenic shock secondary to acute myocardial infarction (AMI). Cardiogenic shock is characterized by a sustained systolic blood pressure < 90 mmHg, evidence of end-organ hypoperfusion, and a low cardiac index (< 2.2 L/min/m²) despite adequate filling pressures. In AMI patients, persistent low cardiac output and elevated systemic vascular resistance exacerbate tissue hypoxia, leading to multi-organ dysfunction.
Upon ICU admission, a pulmonary artery catheter will be inserted via the internal jugular or subclavian vein. Continuous measurements of right atrial pressure (RAP), right ventricular pressure, pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (via thermodilution), and mixed venous oxygen saturation (SvO₂) will be recorded at baseline and predefined intervals (0, 3, 6, 9, 12, 24 hours). Data will guide titration of inotropes (e.g., dobutamine targeting cardiac index ≥ 2.2 L/min/m²), vasopressors (e.g., norepinephrine to maintain MAP ≥ 65 mmHg), and fluid management (to achieve PCWP from 12 to 18 mmHg and CVP between 8 to 12 mmHg), SvO₂ keep above 60% to 80%, lactat < 2 mmol/L.
The primary endpoint is 30-day all-cause mortality and in-hospital mortality. Secondary endpoints include duration of vasopressor/inotrope support, ICU length of stay, incidence of acute kidney injury, and catheter-related adverse events. Hemodynamic variables will be analyzed for outcomes using multivariate regression to identify predictors of successful hemodynamic stabilization.
All enrolled patients (n ≈ 108) will receive standard AMI care, including early revascularization and guideline-directed medical therapy in conjunction with the study protocol. Data collection, storage, and analysis will comply with Good Clinical Practice and the institution's ethics board requirements. Participation is voluntary, and patients may withdraw at any time without affecting their clinical management.
- Conditions
- Cardiogenic Shock, Pulmonary Artery Catheter Waveform Interpretation, Hemodynamic Management, Hemodynamic Optimization, Hemodynamic Monitoring, Acute Myocardial Infarction (AMI)
- Being tested
- Swan-Ganz IQ Pulmonary Arterial catheter, Swan-Ganz IQ catheter
- Keywords
- Swan-Ganz, Pulmonary Artery Catheter, Cardiogenic shock, Hemodynamic management, Invasive hemodynamic, Right Heart Catheter
- Medical subject headings
- Shock, Cardiogenic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swan-Ganz IQ Pulmonary Arterial catheterDevice
Also called Flow-Directed Cathete, Plumonary Artery Catheter Swan-Ganz, Swan-Ganz catheterization, PAC
A pulmonary artery catheter (Swan-Ganz catheter) will be inserted via the right internal jugular or subclavian vein using a sterile technique and ultrasound guidance. The catheter is advanced into the pulmonary artery with real-time pressure waveform monitoring to confirm accurate positioning.
Once inserted, the catheter provides continuous invasive hemodynamic monitoring, including measurements of: Right atrial pressure (RAP), Pulmonary artery pressure (PAP), Pulmonary capillary wedge pressure (PCWP), Cardiac output (CO) by thermodilution, Mixed venous oxygen saturation (SvO₂).
These parameters are recorded at predefined intervals and used to guide goal-directed hemodynamic resuscitation. Clinical interventions such as vasopressor/inotrope titration, fluid resuscitation, or ventilatory support will be adjusted accordingly. All procedures will follow institutional protocols and safety standards. Complications (e.g., arrhythmias, infection) will be monitored and managed per protocol.
Swan-Ganz IQ catheterDevice
Also called Cardiovascular Diagnostic Catheters, Pulmonary Artery Catheter, Swan-Ganz catheterization, Invasive hemodynamic monitoring
A pulmonary artery catheter (Swan-Ganz catheter) will be inserted via the right internal jugular or subclavian vein using a sterile technique and ultrasound guidance. The catheter is advanced into the pulmonary artery with real-time pressure waveform monitoring to confirm accurate positioning.
Once inserted, the catheter provides continuous invasive hemodynamic monitoring, including measurements of: Right atrial pressure (RAP), Pulmonary artery pressure (PAP), Pulmonary capillary wedge pressure (PCWP), Cardiac output (CO) by thermodilution, Mixed venous oxygen saturation (SvO₂). These parameters are recorded at predefined intervals and used to guide goal-directed hemodynamic resuscitation. Clinical interventions such as vasopressor/inotrope titration, fluid resuscitation, or ventilatory support will be adjusted accordingly. All procedures will follow institutional protocols and safety standards. Complications (e.g., arrhythmias, infection) will be monitored and managed per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Swan-Ganz-Guided Hemodynamic Resuscitation | Experimental | Participants in this arm will undergo invasive hemodynamic monitoring using a Swan-Ganz catheter upon admission to the intensive care unit. Hemodynamic variables, including right atrial pressure (RAP), pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), cardiac power output (CPO), and mixed venous oxygen saturation (SvO₂) will be continuously measured and used to guide resuscitation. Management will follow a goal-directed algorithm targeting predefined thresholds for preload, afterload, contractility, and oxygen delivery. All patients will receive standard care for acute myocardial infarction, and no control or comparator arm is included in this study. Receives: Device: Swan-Ganz IQ Pulmonary Arterial catheter; Device: Swan-Ganz IQ catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality at 30 Days
The proportion of participants who die from any cause within 30 days of Swan-Ganz catheter insertion. Mortality will be determined by review of hospital medical records, ICU documentation, or death certificates.
Measured: From the date of Swan-Ganz catheter insertion until the date of death from any cause, assessed up to 30 days
In-Hospital Mortality
Proportion of enrolled patients who die from any cause during the index hospitalization after Swan-Ganz catheter insertion. Mortality will be determined by review of hospital medical records, ICU documentation.
Measured: From the date of Swan-Ganz catheter insertion until the hospital discharge date or the in-hospital death date, whichever comes first.
Hemodynamic stabilization was achieved within 24 hours
Proportion of patients achieving predefined hemodynamic targets within 24 hours following Swan-Ganz catheter insertion. Targets include mean arterial pressure (MAP) ≥ 65 mmHg, cardiac index (CI) ≥ 2.2 L/min/m², central venous oxygen saturation (SvO₂) ≥ 60%, pulmonary capillary wedge pressure (PCWP) between 12 and 18 mmHg, and central venous pressure (CVP) between 8 and 12 mmHg.
Measured: Up to 24 hours after Swan-Ganz catheter insertion
Secondary outcomes (4)
Length of ICU stay
Total number of days from emergency department ICU admission to emergency department ICU discharge for each participant.
Measured: From the date of ICU admission until the date of ICU discharge, assessed up to 30 days.
Incidence of Catheter-Related Complications
The incidence of specific complications related to Swan-Ganz catheterization will be assessed, including ventricular arrhythmias, catheter malposition, CLABSI, bleeding at the insertion site, pneumothorax, hematoma, pericardial effusion, pulmonary artery catheter obstruction, thrombosis, and local site complications. Each complication will be reported individually as a percentage of the total study population.
Measured: From the date of Swan-Ganz catheter insertion until the date of catheter removal, assessed up to 30 days.
Duration of Mechanical Ventilation (Ventilator Days)
Number of calendar days that the patient remains on invasive mechanical ventilation from the time of endotracheal intubation until successful extubation or death. Reintubation within 48 hours will be considered part of the same ventilation episode.
Measured: From the date of endotracheal intubation and mechanical ventilation until the date of weaning mechanical ventilation success or death, assessed up to 30 days.
Continuous Requirement for Renal Replacement Therapy (CRRT)
Proportion of participants who require any form of renal replacement therapy (intermittent hemodialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) during the index hospitalization for cardiogenic shock.
Measured: From the date of emergency department admission until the date of hospital discharge or death, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start27 May 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm clinical trial conducted in an intensive care setting. All enrolled patients diagnosed with cardiogenic shock secondary to acute myocardial infarction will undergo goal-directed hemodynamic resuscitation guided by pulmonary artery catheter (Swan-Ganz) monitoring. The study employs a within-subject design, in which each participant serves as their own temporal control through serial hemodynamic assessments and treatment adjustments. There is no comparator or control group. The protocol includes standardized targets for preload, afterload, cardiac output, and oxygen delivery parameters, with data collected at predefined time points to evaluate hemodynamic response, organ perfusion, and short-term clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bach Mai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University
- Responsible party
- Principal investigator, Thang Pham, Bach Mai Hospital
- Investigators
- Thang Xuan Pham, MD, PhD Candidate, Principal investigator, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062744
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tehrani BN, Truesdell AG, Psotka MA, Rosner C, Singh R, Sinha SS, Damluji AA, Batchelor WB. A Standardized and Comprehensive Approach to the Management of Cardiogenic Shock. JACC Heart Fail. 2020 Nov;8(11):879-891. doi: 10.1016/j.jchf.2020.09.005.
PubMed 33121700Bertaina M, Galluzzo A, Rossello X, Sbarra P, Petitti E, Prever SB, Boccuzzi G, D'Ascenzo F, Frea S, Pidello S, Morici N, Sacco A, Oliva F, Valente S, De Ferrari GM, Ugo F, Rametta F, Attisani M, Zanini P, Noussan P, Iannaccone M. Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies. J Crit Care. 2022 Jun;69:154024. doi: 10.1016/j.jcrc.2022.154024. Epub 2022 Mar 25.
PubMed 35344825Tehrani BN, Truesdell AG, Sherwood MW, Desai S, Tran HA, Epps KC, Singh R, Psotka M, Shah P, Cooper LB, Rosner C, Raja A, Barnett SD, Saulino P, deFilippi CR, Gurbel PA, Murphy CE, O'Connor CM. Standardized Team-Based Care for Cardiogenic Shock. J Am Coll Cardiol. 2019 Apr 9;73(13):1659-1669. doi: 10.1016/j.jacc.2018.12.084.
PubMed 30947919Chetana Shanmukhappa S, Lokeshwaran S. Venous Oxygen Saturation. 2024 Sep 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564395/
PubMed 33232065Kadosh BS, Berg DD, Bohula EA, Park JG, Baird-Zars VM, Alviar C, Alzate J, Barnett CF, Barsness GW, Burke J, Chaudhry SP, Daniels LB, DeFilippis A, Delicce A, Fordyce CB, Ghafghazi S, Gidwani U, Goldfarb M, Katz JN, Keeley EC, Kenigsberg B, Kontos MC, Lawler PR, Leibner E, Menon V, Metkus TS, Miller PE, O'Brien CG, Papolos AI, Prasad R, Shah KS, Sinha SS, Snell RJ, So D, Solomon MA, Ternus BW, Teuteberg JJ, Toole J, van Diepen S, Morrow DA, Roswell RO. Pulmonary Artery Catheter Use and Mortality in the Cardiac Intensive Care Unit. JACC Heart Fail. 2023 Aug;11(8 Pt 1):903-914. doi: 10.1016/j.jchf.2023.04.007. Epub 2023 Jun 14.
PubMed 37318422Hunziker L, Radovanovic D, Jeger R, Pedrazzini G, Cuculi F, Urban P, Erne P, Rickli H, Pilgrim T; AMIS Plus Registry Investigators are listed in alphabetic order with the names of the local principal investigators. Twenty-Year Trends in the Incidence and Outcome of Cardiogenic Shock in AMIS Plus Registry. Circ Cardiovasc Interv. 2019 Apr;12(4):e007293. doi: 10.1161/CIRCINTERVENTIONS.118.007293.
PubMed 30943781Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014 Jan 13;3(1):e000590. doi: 10.1161/JAHA.113.000590.
PubMed 24419737Goldberg RJ, Spencer FA, Gore JM, Lessard D, Yarzebski J. Thirty-year trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective. Circulation. 2009 Mar 10;119(9):1211-9. doi: 10.1161/CIRCULATIONAHA.108.814947. Epub 2009 Feb 23.
PubMed 19237658Chow JY, Vadakken ME, Whitlock RP, Koziarz A, Ainsworth C, Amin F, McIntyre WF, Demers C, Belley-Cote EP. Pulmonary artery catheterization in patients with cardiogenic shock: a systematic review and meta-analysis. Can J Anaesth. 2021 Nov;68(11):1611-1629. doi: 10.1007/s12630-021-02083-2. Epub 2021 Aug 17.
PubMed 34405356Rea ABBAC, Mihajlovic V, Vishram-Nielsen JKK, Brahmbhatt DH, Scolari FL, Wang VN, Nisar M, Fung NL, Otsuki M, Billia F, Overgaard CB, Luk A. Pulmonary Artery Catheter Usage and Impact on Mortality in Patients With Cardiogenic Shock: Results From a Canadian Single-Centre Registry. Can J Cardiol. 2024 Apr;40(4):664-673. doi: 10.1016/j.cjca.2023.12.005. Epub 2023 Dec 12.
PubMed 38092192Bertaina M, Galluzzo A, Morici N, Sacco A, Oliva F, Valente S, D'Ascenzo F, Frea S, Sbarra P, Petitti E, Prever SB, Boccuzzi G, Zanini P, Attisani M, Rametta F, De Ferrari GM, Noussan P, Iannaccone M. Pulmonary Artery Catheter Monitoring in Patients with Cardiogenic Shock: Time for a Reappraisal? Card Fail Rev. 2022 Apr 26;8:e15. doi: 10.15420/cfr.2021.32. eCollection 2022 Jan.
PubMed 35541286Thiele H, Zeymer U, Thelemann N, Neumann FJ, Hausleiter J, Abdel-Wahab M, Meyer-Saraei R, Fuernau G, Eitel I, Hambrecht R, Bohm M, Werdan K, Felix SB, Hennersdorf M, Schneider S, Ouarrak T, Desch S, de Waha-Thiele S; IABP-SHOCK II Trial (Intraaortic Balloon Pump in Cardiogenic Shock II) Investigators; IABP-SHOCK II Investigators. Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial. Circulation. 2019 Jan 15;139(3):395-403. doi: 10.1161/CIRCULATIONAHA.118.038201. Epub 2018 Nov 11.
PubMed 30586721van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18.
PubMed 28923988Garan AR, Kanwar M, Thayer KL, Whitehead E, Zweck E, Hernandez-Montfort J, Mahr C, Haywood JL, Harwani NM, Wencker D, Sinha SS, Vorovich E, Abraham J, O'Neill W, Burkhoff D, Kapur NK. Complete Hemodynamic Profiling With Pulmonary Artery Catheters in Cardiogenic Shock Is Associated With Lower In-Hospital Mortality. JACC Heart Fail. 2020 Nov;8(11):903-913. doi: 10.1016/j.jchf.2020.08.012.
PubMed 33121702Yoo TK, Miyashita S, Davoudi F, Imahira U, Al-Obaidi A, Chweich H, Huggins GS, Kimmelstiel C, Kapur NK. Clinical impact of pulmonary artery catheter in patients with cardiogenic shock: A systematic review and meta-analysis. Cardiovasc Revasc Med. 2023 Oct;55:58-65. doi: 10.1016/j.carrev.2023.04.008. Epub 2023 Apr 17.
PubMed 37100652
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Swan-Ganz Catheter in Hemodynamic Resuscitation for Patients With Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07062744
- Acronym / sponsor ID
- 1
- Conditions
- Cardiogenic Shock, Pulmonary Artery Catheter Waveform Interpretation, Hemodynamic Management, Hemodynamic Optimization, Hemodynamic Monitoring, Acute Myocardial Infarction (AMI)
- Keywords
- Swan-Ganz, Pulmonary Artery Catheter, Cardiogenic shock, Hemodynamic management, Invasive hemodynamic, Right Heart Catheter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Bach Mai HospitalUniversity, hospital or other
- Collaborators
- Hanoi Medical University
- Study start
- 27 May 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial examines whether the use of the Swan-Ganz catheter, a specialized pulmonary artery catheter, can improve hemodynamic management and treatment outcomes in patients experiencing cardiogenic shock due to acute myocardial infarction (AMI).
Cardiogenic shock is a critical condition marked by the heart's inability to supply adequate blood to the organs, often resulting from a severe heart attack. Despite advancements in care, the condition remains associated with high mortality. Effective monitoring of cardiovascular status is crucial in guiding timely and tailored treatment decisions.
Participants in this study will undergo advanced hemodynamic monitoring using the Swan-Ganz catheter, which provides continuous data on cardiac output and other key parameters. This information enables physicians to better assess circulatory function and adjust therapies accordingly.
The research will evaluate clinical characteristics, response to treatment, and 30-day outcomes in patients managed with this technique. The study also aims to identify factors associated with successful hemodynamic stabilization and potential complications related to catheter use.
A total of 108 adult patients meeting specific eligibility criteria will be enrolled at Bach Mai Hospital over 3 years. Participation is voluntary, and all patients will continue to receive standard-of-care treatment. All personal and medical data will be handled with strict confidentiality.
Detailed description
This is a clinical trial without a control group; a single-center study evaluates goal-directed hemodynamic optimization using pulmonary artery catheterization (Swan-Ganz catheter) in adult patients with cardiogenic shock secondary to acute myocardial infarction (AMI). Cardiogenic shock is characterized by a sustained systolic blood pressure < 90 mmHg, evidence of end-organ hypoperfusion, and a low cardiac index (< 2.2 L/min/m²) despite adequate filling pressures. In AMI patients, persistent low cardiac output and elevated systemic vascular resistance exacerbate tissue hypoxia, leading to multi-organ dysfunction.
Upon ICU admission, a pulmonary artery catheter will be inserted via the internal jugular or subclavian vein. Continuous measurements of right atrial pressure (RAP), right ventricular pressure, pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (via thermodilution), and mixed venous oxygen saturation (SvO₂) will be recorded at baseline and predefined intervals (0, 3, 6, 9, 12, 24 hours). Data will guide titration of inotropes (e.g., dobutamine targeting cardiac index ≥ 2.2 L/min/m²), vasopressors (e.g., norepinephrine to maintain MAP ≥ 65 mmHg), and fluid management (to achieve PCWP from 12 to 18 mmHg and CVP between 8 to 12 mmHg), SvO₂ keep above 60% to 80%, lactat < 2 mmol/L.
The primary endpoint is 30-day all-cause mortality and in-hospital mortality. Secondary endpoints include duration of vasopressor/inotrope support, ICU length of stay, incidence of acute kidney injury, and catheter-related adverse events. Hemodynamic variables will be analyzed for outcomes using multivariate regression to identify predictors of successful hemodynamic stabilization.
All enrolled patients (n ≈ 108) will receive standard AMI care, including early revascularization and guideline-directed medical therapy in conjunction with the study protocol. Data collection, storage, and analysis will comply with Good Clinical Practice and the institution's ethics board requirements. Participation is voluntary, and patients may withdraw at any time without affecting their clinical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm clinical trial conducted in an intensive care setting. All enrolled patients diagnosed with cardiogenic shock secondary to acute myocardial infarction will undergo goal-directed hemodynamic resuscitation guided by pulmonary artery catheter (Swan-Ganz) monitoring. The study employs a within-subject design, in which each participant serves as their own temporal control through serial hemodynamic assessments and treatment adjustments. There is no comparator or control group. The protocol includes standardized targets for preload, afterload, cardiac output, and oxygen delivery parameters, with data collected at predefined time points to evaluate hemodynamic response, organ perfusion, and short-term clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| Swan-Ganz-Guided Hemodynamic Resuscitation | Experimental | Device: Swan-Ganz IQ Pulmonary Arterial catheter, Device: Swan-Ganz IQ catheterParticipants in this arm will undergo invasive hemodynamic monitoring using a Swan-Ganz catheter upon admission to the intensive care unit. Hemodynamic variables, including right atrial pressure (RAP), pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), cardiac power output (CPO), and mixed venous oxygen saturation (SvO₂) will be continuously measured and used to guide resuscitation. Management will follow a goal-directed algorithm targeting predefined thresholds for preload, afterload, contractility, and oxygen delivery. All patients will receive standard care for acute myocardial infarction, and no control or comparator arm is included in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Provided written informed consent to participate in the study.
- Diagnosed with cardiogenic shock due to acute myocardial infarction according to IABP-SHOCK II (2012) criteria:
Key exclusion criteria (6 listed)
- Presence of cervical cellulitis.
- Inability to identify neck anatomy or history of cervical radiotherapy.
- Coagulopathy (INR > 1.5 and/or platelet count < 50 G/L).
- End-stage chronic diseases, including: Advanced malignancy, advanced-stage HIV, bedridden patients for more than 3 months, decompensated liver cirrhosis (Child-Pugh class C).
- Patients with cardiac arrest or mechanical complications such as myocardial rupture prior to Swan-Ganz catheterization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swan-Ganz IQ Pulmonary Arterial catheterAlso: Flow-Directed Cathete, Plumonary Artery Catheter Swan-Ganz, Swan-Ganz catheterization, PACA pulmonary artery catheter (Swan-Ganz catheter) will be inserted via the right internal jugular or subclavian vein using a sterile technique and ultrasound guidance. The catheter is advanced into the pulmonary artery with real-time pressure waveform monitoring to confirm accurate positioning. Once inserted, the catheter provides continuous invasive hemodynamic monitoring, including measurements of: Right atrial pressure (RAP), Pulmonary artery pressure (PAP), Pulmonary capillary wedge pressure (PCWP), Cardiac output (CO) by thermodilution, Mixed venous oxygen saturation (SvO₂). These parameters are recorded at predefined intervals and used to guide goal-directed hemodynamic resuscitation. Clinical interventions such as vasopressor/inotrope titration, fluid resuscitation, or ventilatory support will be adjusted accordingly. All procedures will follow institutional protocols and safety standards. Complications (e.g., arrhythmias, infection) will be monitored and managed per protocol. | Device | Swan-Ganz-Guided Hemodynamic Resuscitation |
| Swan-Ganz IQ catheterAlso: Cardiovascular Diagnostic Catheters, Pulmonary Artery Catheter, Swan-Ganz catheterization, Invasive hemodynamic monitoringA pulmonary artery catheter (Swan-Ganz catheter) will be inserted via the right internal jugular or subclavian vein using a sterile technique and ultrasound guidance. The catheter is advanced into the pulmonary artery with real-time pressure waveform monitoring to confirm accurate positioning. Once inserted, the catheter provides continuous invasive hemodynamic monitoring, including measurements of: Right atrial pressure (RAP), Pulmonary artery pressure (PAP), Pulmonary capillary wedge pressure (PCWP), Cardiac output (CO) by thermodilution, Mixed venous oxygen saturation (SvO₂). These parameters are recorded at predefined intervals and used to guide goal-directed hemodynamic resuscitation. Clinical interventions such as vasopressor/inotrope titration, fluid resuscitation, or ventilatory support will be adjusted accordingly. All procedures will follow institutional protocols and safety standards. Complications (e.g., arrhythmias, infection) will be monitored and managed per protocol. | Device | Swan-Ganz-Guided Hemodynamic Resuscitation |
Primary outcome
All-Cause Mortality at 30 Days
Time frame: From the date of Swan-Ganz catheter insertion until the date of death from any cause, assessed up to 30 days
The proportion of participants who die from any cause within 30 days of Swan-Ganz catheter insertion. Mortality will be determined by review of hospital medical records, ICU documentation, or death certificates.
In-Hospital Mortality
Time frame: From the date of Swan-Ganz catheter insertion until the hospital discharge date or the in-hospital death date, whichever comes first.
Proportion of enrolled patients who die from any cause during the index hospitalization after Swan-Ganz catheter insertion. Mortality will be determined by review of hospital medical records, ICU documentation.
Hemodynamic stabilization was achieved within 24 hours
Time frame: Up to 24 hours after Swan-Ganz catheter insertion
Proportion of patients achieving predefined hemodynamic targets within 24 hours following Swan-Ganz catheter insertion. Targets include mean arterial pressure (MAP) ≥ 65 mmHg, cardiac index (CI) ≥ 2.2 L/min/m², central venous oxygen saturation (SvO₂) ≥ 60%, pulmonary capillary wedge pressure (PCWP) between 12 and 18 mmHg, and central venous pressure (CVP) between 8 and 12 mmHg.
4 secondary outcomes
Length of ICU stay
Time frame: From the date of ICU admission until the date of ICU discharge, assessed up to 30 days.
Incidence of Catheter-Related Complications
Time frame: From the date of Swan-Ganz catheter insertion until the date of catheter removal, assessed up to 30 days.
Duration of Mechanical Ventilation (Ventilator Days)
Time frame: From the date of endotracheal intubation and mechanical ventilation until the date of weaning mechanical ventilation success or death, assessed up to 30 days.
Continuous Requirement for Renal Replacement Therapy (CRRT)
Time frame: From the date of emergency department admission until the date of hospital discharge or death, assessed up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 33121700Tehrani BN, Truesdell AG, Psotka MA, Rosner C, Singh R, Sinha SS, Damluji AA, Batchelor WB. A Standardized and Comprehensive Approach to the Management of Cardiogenic Shock. JACC Heart Fail. 2020 Nov;8(11):879-891. doi: 10.1016/j.jchf.2020.09.005.
- Background: PubMed 35344825Bertaina M, Galluzzo A, Rossello X, Sbarra P, Petitti E, Prever SB, Boccuzzi G, D'Ascenzo F, Frea S, Pidello S, Morici N, Sacco A, Oliva F, Valente S, De Ferrari GM, Ugo F, Rametta F, Attisani M, Zanini P, Noussan P, Iannaccone M. Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies. J Crit Care. 2022 Jun;69:154024. doi: 10.1016/j.jcrc.2022.154024. Epub 2022 Mar 25.
- Background: PubMed 30947919Tehrani BN, Truesdell AG, Sherwood MW, Desai S, Tran HA, Epps KC, Singh R, Psotka M, Shah P, Cooper LB, Rosner C, Raja A, Barnett SD, Saulino P, deFilippi CR, Gurbel PA, Murphy CE, O'Connor CM. Standardized Team-Based Care for Cardiogenic Shock. J Am Coll Cardiol. 2019 Apr 9;73(13):1659-1669. doi: 10.1016/j.jacc.2018.12.084.
- Background: PubMed 33232065Chetana Shanmukhappa S, Lokeshwaran S. Venous Oxygen Saturation. 2024 Sep 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564395/
- Background: PubMed 37318422Kadosh BS, Berg DD, Bohula EA, Park JG, Baird-Zars VM, Alviar C, Alzate J, Barnett CF, Barsness GW, Burke J, Chaudhry SP, Daniels LB, DeFilippis A, Delicce A, Fordyce CB, Ghafghazi S, Gidwani U, Goldfarb M, Katz JN, Keeley EC, Kenigsberg B, Kontos MC, Lawler PR, Leibner E, Menon V, Metkus TS, Miller PE, O'Brien CG, Papolos AI, Prasad R, Shah KS, Sinha SS, Snell RJ, So D, Solomon MA, Ternus BW, Teuteberg JJ, Toole J, van Diepen S, Morrow DA, Roswell RO. Pulmonary Artery Catheter Use and Mortality in the Cardiac Intensive Care Unit. JACC Heart Fail. 2023 Aug;11(8 Pt 1):903-914. doi: 10.1016/j.jchf.2023.04.007. Epub 2023 Jun 14.
- Background: PubMed 30943781Hunziker L, Radovanovic D, Jeger R, Pedrazzini G, Cuculi F, Urban P, Erne P, Rickli H, Pilgrim T; AMIS Plus Registry Investigators are listed in alphabetic order with the names of the local principal investigators. Twenty-Year Trends in the Incidence and Outcome of Cardiogenic Shock in AMIS Plus Registry. Circ Cardiovasc Interv. 2019 Apr;12(4):e007293. doi: 10.1161/CIRCINTERVENTIONS.118.007293.
- Background: PubMed 24419737Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014 Jan 13;3(1):e000590. doi: 10.1161/JAHA.113.000590.
- Background: PubMed 19237658Goldberg RJ, Spencer FA, Gore JM, Lessard D, Yarzebski J. Thirty-year trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective. Circulation. 2009 Mar 10;119(9):1211-9. doi: 10.1161/CIRCULATIONAHA.108.814947. Epub 2009 Feb 23.
- Background: PubMed 34405356Chow JY, Vadakken ME, Whitlock RP, Koziarz A, Ainsworth C, Amin F, McIntyre WF, Demers C, Belley-Cote EP. Pulmonary artery catheterization in patients with cardiogenic shock: a systematic review and meta-analysis. Can J Anaesth. 2021 Nov;68(11):1611-1629. doi: 10.1007/s12630-021-02083-2. Epub 2021 Aug 17.
- Background: PubMed 38092192Rea ABBAC, Mihajlovic V, Vishram-Nielsen JKK, Brahmbhatt DH, Scolari FL, Wang VN, Nisar M, Fung NL, Otsuki M, Billia F, Overgaard CB, Luk A. Pulmonary Artery Catheter Usage and Impact on Mortality in Patients With Cardiogenic Shock: Results From a Canadian Single-Centre Registry. Can J Cardiol. 2024 Apr;40(4):664-673. doi: 10.1016/j.cjca.2023.12.005. Epub 2023 Dec 12.
- Background: PubMed 35541286Bertaina M, Galluzzo A, Morici N, Sacco A, Oliva F, Valente S, D'Ascenzo F, Frea S, Sbarra P, Petitti E, Prever SB, Boccuzzi G, Zanini P, Attisani M, Rametta F, De Ferrari GM, Noussan P, Iannaccone M. Pulmonary Artery Catheter Monitoring in Patients with Cardiogenic Shock: Time for a Reappraisal? Card Fail Rev. 2022 Apr 26;8:e15. doi: 10.15420/cfr.2021.32. eCollection 2022 Jan.
- Background: PubMed 30586721Thiele H, Zeymer U, Thelemann N, Neumann FJ, Hausleiter J, Abdel-Wahab M, Meyer-Saraei R, Fuernau G, Eitel I, Hambrecht R, Bohm M, Werdan K, Felix SB, Hennersdorf M, Schneider S, Ouarrak T, Desch S, de Waha-Thiele S; IABP-SHOCK II Trial (Intraaortic Balloon Pump in Cardiogenic Shock II) Investigators; IABP-SHOCK II Investigators. Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial. Circulation. 2019 Jan 15;139(3):395-403. doi: 10.1161/CIRCULATIONAHA.118.038201. Epub 2018 Nov 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thang Xuan Pham, MD, PhD Candidate principal investigator
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swan-Ganz IQ Pulmonary Arterial catheter and Swan-Ganz IQ catheter in people with Cardiogenic Shock and Pulmonary Artery Catheter Waveform Interpretation, run by Bach Mai Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thang Xuan Pham, MD, PhD Candidate (+84357991992, pxthanghmu92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality at 30 Days (time frame: From the date of Swan-Ganz catheter insertion until the date of death from any cause, assessed up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07062744, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.