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SepsisNCT06887140

Prognostic Value of Right Ventricular-pulmonary Arterial Coupling Assessed by Echocardiography in Septic Patients

An observational study of Sepsis, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Sepsis and septic shock are common clinical conditions, representing a significant healthcare challenge due to their high mortality rates and increasing incidence. Sepsis-induced cardiomyopathy is a frequent complication, occurring in up to 44% of septic patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
What is being tested?
Echocardiography
How many people
215 participants
Where
1 siteVietnam
Study dates
16 Apr 2025to Feb 2027
Phase
Observational
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

Study population: All patients received treatment in the Intensive Care Unit (ICU) at the University Medical Center at Ho Chi Minh City during the study period

Who may be able to join

  • Diagnosed with sepsis,
  • Received treatment in the Intensive Care Unit (ICU) at the University Medical Center at Ho Chi Minh City during the study period.

Who cannot join

  • Pregnancy,
  • History of right ventricular myocardial infarction,
  • Acute coronary syndrome within the past 1 week,
  • Valvular heart diseases or a history of valve replacement surgery,
  • Congenital heart diseases or conditions involving intracardiac shunts.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anh-Minh V Phan, MSc. contact

+84907216232

minh.pva@umc.edu.vn

Khoi M Le, A/Prof. Dr. contact

+84919731386

khoi.lm@umc.edu.vn

Vietnam1 site, 1 recruiting
  • University Medical Center

    Ho Chi Minh City, 700000

    Khoi Minh Le, A/Prof. Dr., +84919731386, khoi.lm@umc.edu.vn

    Quynh Xuan Nguyen, +84336514303, quynh.nx@umc.edu.vn

    Recruiting

Other trials in Vietnam

About this study

Official title: Prognostic Value of Right Ventricular-pulmonary Arterial Coupling Assessed by Echocardiography in Septic Patients: A Prospective Observational Study

Sepsis and septic shock are common clinical conditions, representing a significant healthcare challenge due to their high mortality rates and increasing incidence. Sepsis-induced cardiomyopathy is a frequent complication, occurring in up to 44% of septic patients. This condition is associated with a two- to three-fold increase in mortality. Although sepsis-induced cardiomyopathy is typically diagnosed via echocardiography to assess left ventricular systolic function, both ventricles may be affected. Several studies have demonstrated that right ventricular dysfunction (RVD)/ right ventricular failure (RVF) was prevalent in sepsis and septic shock, with significant implications for prognosis and mortality.

The right ventricle (RV) has a distinct anatomical structure and function compared to the left ventricle, characterized by its high sensitivity to afterload variations. Even minor increases in afterload can severely impair RV contractile function. Meanwhile, septic patients often experience hypoxemic respiratory failure and require mechanical ventilation. This condition generates hypoxia-induced pulmonary vasoconstriction, which, combined with positive pressure ventilation, leads to increased pulmonary vascular resistance and elevated pulmonary arterial pressure. Additionally, systemic vasodilation reduces RV preload, while septic shock and vasopressor use further compromise right coronary perfusion, exacerbating RV contractile dysfunction. Consequently, simultaneous assessment of RV contractility and its afterload is crucial in septic patients.

Read more

Tricuspid annular plane systolic excursion (TAPSE) is a widely used echocardiographic parameter for evaluating RV systolic function. Pulmonary artery systolic pressure (sPAP) reflects RV afterload and can be estimated in the presence of tricuspid regurgitation. Recently, the TAPSE/sPAP ratio has been proposed as a clinical tool to assess right ventricle-pulmonary artery (RV-PA) coupling. This index has been shown to be associated with mortality in patients with pulmonary hypertension and heart failure. Several studies have been conducted to evaluate RV-PA coupling in sepsis and septic shocks, but these studies have limitations in terms of study design and patient selection.

In Vietnam, the issues of RVD/RVF in sepsis/septic shock have not been thoroughly investigated. Le Minh Khoi and colleagues reported that the incidence of reduced RV strain in septic patients was as high as 55.1%. Currently, no studies have specifically evaluated RV function, nor have any studies assessed RV-PA coupling in septic patients.

Conditions
Sepsis
Being tested
Echocardiography
Keywords
Sepsis, Septic shock, Sepsis-induced Cardiomyopathy, Right ventricle-pulmonary artery coupling, Echocardiography
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EchocardiographyDiagnostic test

    • First echocardiography: within 24 hours after study enrollment,
    • Second echocardiography: 48-72 hours after the initial echocardiography.
    • The recorded echocardiographic parameters include:
    • Morphological and Functional Parameters
    • Mitral Valve Flow Parameters
    • Tissue Doppler Echocardiography Parameters
    • STE Parameters for Left Ventricle Assessment
    • STE Parameters for Right Ventricle Assessment
Study groups in NCT06887140
Study groupRoleWhat they receive
Septic patients not having right ventricle-pulmonary artery uncouplingNot described
Receives: Diagnostic Test: Echocardiography
Septic patients having right ventricle-pulmonary artery uncouplingNot described
Receives: Diagnostic Test: Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital mortality

    Measured: Feb 2027

Secondary outcomes (4)
  1. Duration of mechanical ventilation

    Measured: Feb 2027

  2. Length of stay in Intensive Care Unit

    Measured: Feb 2027

  3. Length of stay in hospital

    Measured: Feb 2027

  4. Mortality in Intensive Care Unit

    Measured: Feb 2027

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start16 Apr 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
215 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06887140
Sponsor's protocol ID
173/GCN-HDDD
Status last verified
Apr 2026
First submitted
14 Mar 2025
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

    PubMed 31954465
  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PubMed 26903338
  • Ehrman RR, Sullivan AN, Favot MJ, Sherwin RL, Reynolds CA, Abidov A, Levy PD. Pathophysiology, echocardiographic evaluation, biomarker findings, and prognostic implications of septic cardiomyopathy: a review of the literature. Crit Care. 2018 May 4;22(1):112. doi: 10.1186/s13054-018-2043-8.

    PubMed 29724231
  • Konstam MA, Kiernan MS, Bernstein D, Bozkurt B, Jacob M, Kapur NK, Kociol RD, Lewis EF, Mehra MR, Pagani FD, Raval AN, Ward C; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; and Council on Cardiovascular Surgery and Anesthesia. Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2018 May 15;137(20):e578-e622. doi: 10.1161/CIR.0000000000000560. Epub 2018 Apr 12.

    PubMed 29650544
  • Mikkelsen ME, Shah CV, Meyer NJ, Gaieski DF, Lyon S, Miltiades AN, Goyal M, Fuchs BD, Bellamy SL, Christie JD. The epidemiology of acute respiratory distress syndrome in patients presenting to the emergency department with severe sepsis. Shock. 2013 Nov;40(5):375-81. doi: 10.1097/SHK.0b013e3182a64682.

    PubMed 23903852
  • Wang S, Bashir Z, Chen EW, Kadiyala V, Sherrod CF, Has P, Song C, Ventetuolo CE, Simmons J, Haines P. Invasive Mechanical Ventilation Is Associated with Worse Right Ventricular Strain in Acute Respiratory Failure Patients. J Cardiovasc Dev Dis. 2024 Aug 9;11(8):246. doi: 10.3390/jcdd11080246.

    PubMed 39195154
  • Repesse X, Charron C, Vieillard-Baron A. Acute respiratory distress syndrome: the heart side of the moon. Curr Opin Crit Care. 2016 Feb;22(1):38-44. doi: 10.1097/MCC.0000000000000267.

    PubMed 26627538
  • Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.

    PubMed 20620859
  • Guazzi M, Naeije R. Pulmonary Hypertension in Heart Failure: Pathophysiology, Pathobiology, and Emerging Clinical Perspectives. J Am Coll Cardiol. 2017 Apr 4;69(13):1718-1734. doi: 10.1016/j.jacc.2017.01.051.

    PubMed 28359519
  • Jentzer JC, Anavekar NS, Reddy YNV, Murphree DH, Wiley BM, Oh JK, Borlaug BA. Right Ventricular Pulmonary Artery Coupling and Mortality in Cardiac Intensive Care Unit Patients. J Am Heart Assoc. 2021 Apr 6;10(7):e019015. doi: 10.1161/JAHA.120.019015. Epub 2021 Mar 28.

    PubMed 33775107
  • Charpentier J, Luyt CE, Fulla Y, Vinsonneau C, Cariou A, Grabar S, Dhainaut JF, Mira JP, Chiche JD. Brain natriuretic peptide: A marker of myocardial dysfunction and prognosis during severe sepsis. Crit Care Med. 2004 Mar;32(3):660-5. doi: 10.1097/01.ccm.0000114827.93410.d8.

    PubMed 15090944
  • Vallabhajosyula S, Kumar M, Pandompatam G, Sakhuja A, Kashyap R, Kashani K, Gajic O, Geske JB, Jentzer JC. Prognostic impact of isolated right ventricular dysfunction in sepsis and septic shock: an 8-year historical cohort study. Ann Intensive Care. 2017 Sep 7;7(1):94. doi: 10.1186/s13613-017-0319-9.

    PubMed 28884343
  • Vieillard-Baron A, Prigent A, Repesse X, Goudelin M, Prat G, Evrard B, Charron C, Vignon P, Geri G. Right ventricular failure in septic shock: characterization, incidence and impact on fluid responsiveness. Crit Care. 2020 Nov 1;24(1):630. doi: 10.1186/s13054-020-03345-z.

    PubMed 33131508
  • Lanspa MJ, Cirulis MM, Wiley BM, Olsen TD, Wilson EL, Beesley SJ, Brown SM, Hirshberg EL, Grissom CK. Right Ventricular Dysfunction in Early Sepsis and Septic Shock. Chest. 2021 Mar;159(3):1055-1063. doi: 10.1016/j.chest.2020.09.274. Epub 2020 Oct 14.

    PubMed 33068615
  • Guazzi M, Bandera F, Pelissero G, Castelvecchio S, Menicanti L, Ghio S, Temporelli PL, Arena R. Tricuspid annular plane systolic excursion and pulmonary arterial systolic pressure relationship in heart failure: an index of right ventricular contractile function and prognosis. Am J Physiol Heart Circ Physiol. 2013 Nov 1;305(9):H1373-81. doi: 10.1152/ajpheart.00157.2013. Epub 2013 Aug 30.

    PubMed 23997100

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis, run by University Medical Center Ho Chi Minh City (UMC) 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 2 inclusion and 5 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 27 May 2026. 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 Anh-Minh V Phan, MSc. (+84907216232, minh.pva@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital mortality (time frame: Feb 2027). 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 NCT06887140, 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 27 May 2026.

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