Cardiovascular DiseasesPRAM-in-HYPONCT05960604
Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients
An observational study of Cardiovascular Diseases and Surgery, run by Recep Tayyip Erdogan University at 5 sites in Turkey (Türkiye).
Trial summary
Perioperative anesthesiologists can benefit from easily obtainable hemodynamic variables detecting or quantifying the lack of an adequate compensatory capacity of the cardiovascular system in order to optimize patient management and improve patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Surgery, Hypotension
- What is being tested?
- Passive leg raising
- How many people
- 660 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 19 Feb 2024to Jun 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: Patients who are scheduled for any major surgery will be included. Major surgery includes a broad list of cardiac surgery, thoracic surgery, hepatic surgery, pancreatic surgery, colorectal surgery, major orthopedic surgeries, cancer surgeries, where blood loss or intravascular volume loss is expected due to factors related to the patient or surgery.
Who may be able to join
- Age at least 18 years
- Undergoing major surgery under general anesthesia
- Expected surgery time >2 h
- Expected length of postoperative stay >2 d
- Invasive blood pressure (radial or femoral) and Mostcare monitoring
- Indication for a passive leg raising test: risk of hypovolemia (preoperative fasting, bowel preparation, loss of appetite, limited access to water) or expected major surgery, expected blood loss, cardiovascular comorbidity (hypertension, diabetes mellitus, coronary artery disease, peripheral artery disease, hyperlipidemia, morbidity, active smoking).
- Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery.
- Ability and willingness to provide informed consent
Who cannot join
- Refuse to consent to the study
- Arterial wave form distortion
- Cardiac arrhythmia
- Inappropriate identification of the dicrotic notch for any reason
- Planned intraoperative mean arterial blood pressure < 65 mmHg
- Hemodynamic instability defined as mean arterial blood pressure < 65 mmHg
Show all 16Show fewer
- Preoperative requirement of inotrope/vasopressor infusion
- Preoperatively receiving vasoactive drugs
- Patients fitted with an intra-aortic balloon pump
- Patients fitted with Extracorporeal Membrane Oxygenation
- Critically ill patients requiring preoperative intensive care unit
- Presence of intraabdominal hypertension
- New York Heart Association Class 3-4 heart failure
- Congestive heart failure with ejection fraction < 35%
- Glomerular filtration rate < 30 ml/min/1.73 m2
- Ongoing renal replacement therapy
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Gazi University Medical Faculty, Department of Anesthesiology and Reanimation
Ankara, 06560
Aycan Özdemirkan, Assoc. Prof., +90-532-7884107, aycan.k@gmail.com
- Recruiting
Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation
Erzurum, 25240
Enes Aydın, Assoc. Prof., +90-554-3318289, EnesMD@msn.com
- Recruiting
Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic
Istanbul, 34480
Taner Abdullah, Asst. Prof, +90-537-5199544, taner.abdullah@gmail.com
- Recruiting
Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation
Istanbul, 34755
Fevzi Toraman, Prof. Dr., +90-216-5004444, ftoraman@gmail.com
- Not yet recruiting
Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
Rize, 53100
Başar Erdivanlı, Assoc. Prof., +90-464-2130491 ext. 2128, basar.erdivanli@erdogan.edu.tr
About this study
Official title: Observational Study to Evaluate the Pressure Recording Analytical Method Parameters in Patients Susceptible to Post-induction Hypotension Due to Hypertension, Diabetes Mellitus, Cardiovascular Risk Factors, or Major Surgery
Perioperative anesthesiologists can benefit from easily obtainable hemodynamic variables detecting or quantifying the lack of an adequate compensatory capacity of the cardiovascular system in order to optimize patient management and improve patient outcomes. Parameters of the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy) of the MostCare system, specifically cardiac cycle efficiency has been proposed as such variables. Yet, their value in anesthesia and especially in hypertensive patients is not studied. The goal of the PRAM-in-HYPO study is to prospectively evaluate the relationship between cardiac reserve and efficiency and cardiovascular risk factors in patients wo will undergo major surgical procedures using the state-of-the-art hemodynamic monitors. Also the investigators aim to build a predictive model to identify patients with decreased cardiac reserve due to hypertension and other cardiovascular risk factors, who are susceptible to post-induction hypotension. The investigators seek to include high-risk patients or patients presenting for major surgery, who are monitored with an advanced hemodynamic monitor to adequately evaluate the differences in cardiac reserve and cardiac efficiency.
Read the detailed description
Untreated hypertension decreases the cardiac reserve through several mechanisms, which are augmented by other cardiovascular risk factors such as diabetes mellitus and coronary artery disease. Perioperative stress on top of these overlapping diseases causes wide variations in the arterial blood pressure. From the anesthesiologist's point of view, this translates into a wide variation in response to surgical stress among patients with seemingly similar cardiovascular risk factors.
The cardiac reserve may be measured by cardiac catheterization or echocardiography, none of which are feasible during a surgery. Recently, some parameters of the Pressure Recording Analytical Method (PRAM) were shown to be affected by hypertension or intraoperative events such as pneumoperitoneum and position changes. This suggests that PRAM may be used to evaluate the risk of adverse hemodynamic events in newly diagnosed, untreated hypertensive patients.
The investigators hypothesized that there is a relationship between hypertension, diabetes mellitus and decreased cardiac reserve and efficiency and that PRAM parameters may identify this. Also, the static or dynamic PRAM parameters may predict pre-incision hypotension in patients wo will undergo major surgical procedures.
In order to test these hypothesis, a prospective cohort study was planned, as the outcome has a very short latency and the intent is to observe the outcome, not to prevent or treat it. The investigators aim to collect high quality hemodynamic data from normotensive, hypertensive, and untreated hypertensive patients. In order to obtain sufficient relevant data, only patients scheduled for major surgeries will be included. Patients who are planned to be monitored with the MostCare hemodynamic monitor, and who need a passive leg raising test will be included in the study.
Hypertension is the most prevalent of cardiovascular risk factors, namely diabetes mellitus, coronary artery disease, smoking, obesity, and dyslipidemia, which may present as either the mediator or cofounder of hypertension. Therefore a detailed medical history including information relevant to these conditions will be collected.
- Conditions
- Cardiovascular Diseases, Surgery, Hypotension, Hypotension on Induction, Hypotension During Surgery
- Being tested
- Passive leg raising
- Keywords
- Mostcare, Pressure Recording Analytical Method, Pulse contour analysis, Hemodynamic monitoring, Effective arterial elastance, Cardiac cycle efficiency, Cardiac power output, Myocardial contraction, Cardiac output, Stroke volume, Systemic vascular resistance
- Medical subject headings
- Cardiovascular Diseases, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive leg raisingDiagnostic test
All patients who met the inclusion criteria will be placed head down flat and feet up at a 45° angle for 30 seconds.
Hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected before, during and after the test until the end of the surgery.
The total duration of the intervention (passive leg raising) is 30 seconds. The total duration of hemodynamic parameters recording is expected to be 60-600 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Low cardiac reserve/efficiency | Patients who were identified as having low cardiac reserve and efficiency, based on PRAM parameters. Receives: Diagnostic Test: Passive leg raising | |
| Normal cardiac reserve/efficiency | Patients who were identified as having normal cardiac reserve and efficiency, based on PRAM parameters. Receives: Diagnostic Test: Passive leg raising |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus
Difference in baseline PRAM parameters between patients who have hypertension, diabetes mellitus and other cardiovascular diseases and those who have none.
Measured: From the start of surgery until the end of surgery
Difference of mean CCE, dP/dt, SVI, CPI, Ea at the 30th second of passive leg raising by hypertension and diabetes mellitus
Difference in the magnitude of the changes observed in PRAM parameters after a passive leg raising test between patients who have hypertension, diabetes mellitus and other cardiovascular diseases and those who have none.
Measured: From the start of passive leg raising test until the end of the test
Secondary outcomes (4)
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Within 5 Minutes Following Tracheal Intubation
Hypotension, defined as mean arterial blood pressure < 65 mmHg, within 5 minutes after tracheal intubation.
Measured: From the start of surgery until the end of surgery
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Between Tracheal Intubation and Surgical Incision
Hypotension, defined as mean arterial blood pressure < 65 mmHg, between 5 minutes after tracheal intubation and surgical incision.
Measured: From the start of surgery until the end of surgery
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg During the Surgery
Hypotension, defined as mean arterial blood pressure < 65 mmHg, between surgical incision and end of surgery.
Measured: From the start of surgery until the end of surgery
Predictive factors of hypotension
Identification of patient characteristics and arterial pressure waveform parameters associated with hypotension. A multiple logistic regression analysis will be performed.
Measured: From the start of surgery until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start19 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care
- Responsible party
- Principal investigator, Başar Erdivanlı, Recep Tayyip Erdogan University
- Investigators
- Fevzi Toraman, Prof., Study director, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960604
- Sponsor's protocol ID
- PRAM-in-HYPO
- Acronym
- PRAM-in-HYPO
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Ethics Committee's approval is required to make individual participant data available to other researchers.
Publications
Choudhry NK, Kronish IM, Vongpatanasin W, Ferdinand KC, Pavlik VN, Egan BM, Schoenthaler A, Houston Miller N, Hyman DJ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology. Medication Adherence and Blood Pressure Control: A Scientific Statement From the American Heart Association. Hypertension. 2022 Jan;79(1):e1-e14. doi: 10.1161/HYP.0000000000000203. Epub 2021 Oct 7.
PubMed 34615363Burnier M, Egan BM. Adherence in Hypertension. Circ Res. 2019 Mar 29;124(7):1124-1140. doi: 10.1161/CIRCRESAHA.118.313220.
PubMed 30920917Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
PubMed 28974066Zhang H, Gao H, Xiang Y, Li J. Maximum inferior vena cava diameter predicts post-induction hypotension in hypertensive patients undergoing non-cardiac surgery under general anesthesia: A prospective cohort study. Front Cardiovasc Med. 2022 Oct 4;9:958259. doi: 10.3389/fcvm.2022.958259. eCollection 2022.
PubMed 36267641Chantler PD, Lakatta EG, Najjar SS. Arterial-ventricular coupling: mechanistic insights into cardiovascular performance at rest and during exercise. J Appl Physiol (1985). 2008 Oct;105(4):1342-51. doi: 10.1152/japplphysiol.90600.2008. Epub 2008 Jul 10.
PubMed 18617626Borlaug BA, Melenovsky V, Redfield MM, Kessler K, Chang HJ, Abraham TP, Kass DA. Impact of arterial load and loading sequence on left ventricular tissue velocities in humans. J Am Coll Cardiol. 2007 Oct 16;50(16):1570-7. doi: 10.1016/j.jacc.2007.07.032. Epub 2007 Oct 1.
PubMed 17936156Ikonomidis I, Aboyans V, Blacher J, Brodmann M, Brutsaert DL, Chirinos JA, De Carlo M, Delgado V, Lancellotti P, Lekakis J, Mohty D, Nihoyannopoulos P, Parissis J, Rizzoni D, Ruschitzka F, Seferovic P, Stabile E, Tousoulis D, Vinereanu D, Vlachopoulos C, Vlastos D, Xaplanteris P, Zimlichman R, Metra M. The role of ventricular-arterial coupling in cardiac disease and heart failure: assessment, clinical implications and therapeutic interventions. A consensus document of the European Society of Cardiology Working Group on Aorta & Peripheral Vascular Diseases, European Association of Cardiovascular Imaging, and Heart Failure Association. Eur J Heart Fail. 2019 Apr;21(4):402-424. doi: 10.1002/ejhf.1436. Epub 2019 Mar 12.
PubMed 30859669Kuznetsova T, D'hooge J, Kloch-Badelek M, Sakiewicz W, Thijs L, Staessen JA. Impact of hypertension on ventricular-arterial coupling and regional myocardial work at rest and during isometric exercise. J Am Soc Echocardiogr. 2012 Aug;25(8):882-90. doi: 10.1016/j.echo.2012.04.018. Epub 2012 May 22.
PubMed 22622108Lam CS, Shah AM, Borlaug BA, Cheng S, Verma A, Izzo J, Oparil S, Aurigemma GP, Thomas JD, Pitt B, Zile MR, Solomon SD. Effect of antihypertensive therapy on ventricular-arterial mechanics, coupling, and efficiency. Eur Heart J. 2013 Mar;34(9):676-83. doi: 10.1093/eurheartj/ehs299. Epub 2012 Sep 10.
PubMed 22963833Guinot PG, Longrois D, Kamel S, Lorne E, Dupont H. Ventriculo-Arterial Coupling Analysis Predicts the Hemodynamic Response to Norepinephrine in Hypotensive Postoperative Patients: A Prospective Observational Study. Crit Care Med. 2018 Jan;46(1):e17-e25. doi: 10.1097/CCM.0000000000002772.
PubMed 29019850Ikonomidis I, Katsanos S, Triantafyllidi H, Parissis J, Tzortzis S, Pavlidis G, Trivilou P, Makavos G, Varoudi M, Frogoudaki A, Vrettou AR, Vlastos D, Lekakis J, Iliodromitis E. Pulse wave velocity to global longitudinal strain ratio in hypertension. Eur J Clin Invest. 2019 Feb;49(2):e13049. doi: 10.1111/eci.13049. Epub 2018 Dec 19.
PubMed 30422317Romano SM. Cardiac cycle efficiency: a new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J Cardiol. 2012 Mar 8;155(2):326-7. doi: 10.1016/j.ijcard.2011.12.008. Epub 2011 Dec 22. No abstract available.
PubMed 22197117Sahiti F, Morbach C, Cejka V, Tiffe T, Wagner M, Eichner FA, Gelbrich G, Heuschmann PU, Stork S. Impact of cardiovascular risk factors on myocardial work-insights from the STAAB cohort study. J Hum Hypertens. 2022 Mar;36(3):235-245. doi: 10.1038/s41371-021-00509-4. Epub 2021 Mar 2.
PubMed 33654241Siripruekpong S, Geater A, Cheewatanakornkul S. Comparison of intraoperative arterial blood pressure lability during general anaesthesia in masked, uncontrolled hypertensive and adequately controlled hypertensive patients: a prospective observational study. Anaesthesiol Intensive Ther. 2022;54(5):402-412. doi: 10.5114/ait.2022.123143.
PubMed 36734451Salim F, Khan F, Nasir M, Ali R, Iqbal A, Raza A. Frequency of Intraoperative Hypotension After the Induction of Anesthesia in Hypertensive Patients with Preoperative Angiotensin-converting Enzyme Inhibitors. Cureus. 2020 Jan 9;12(1):e6614. doi: 10.7759/cureus.6614.
PubMed 32064194
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Pressure Recording Analytical Method Parameters in Patients Susceptible to Post-induction Hypotension Due to Hypertension, Diabetes Mellitus, Cardiovascular Risk Factors, or Major Surgery
- ClinicalTrials.gov ID
- NCT05960604
- Acronym / sponsor ID
- PRAM-in-HYPO / PRAM-in-HYPO
- Conditions
- Cardiovascular Diseases, Surgery, Hypotension, Hypotension on Induction, Hypotension During Surgery
- Keywords
- Mostcare, Pressure Recording Analytical Method, Pulse contour analysis, Hemodynamic monitoring, Effective arterial elastance, Cardiac cycle efficiency, Cardiac power output, Myocardial contraction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Collaborators
- Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Jul 2023 (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.
Perioperative anesthesiologists can benefit from easily obtainable hemodynamic variables detecting or quantifying the lack of an adequate compensatory capacity of the cardiovascular system in order to optimize patient management and improve patient outcomes. Parameters of the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy) of the MostCare system, specifically cardiac cycle efficiency has been proposed as such variables. Yet, their value in anesthesia and especially in hypertensive patients is not studied. The goal of the PRAM-in-HYPO study is to prospectively evaluate the relationship between cardiac reserve and efficiency and cardiovascular risk factors in patients wo will undergo major surgical procedures using the state-of-the-art hemodynamic monitors. Also the investigators aim to build a predictive model to identify patients with decreased cardiac reserve due to hypertension and other cardiovascular risk factors, who are susceptible to post-induction hypotension. The investigators seek to include high-risk patients or patients presenting for major surgery, who are monitored with an advanced hemodynamic monitor to adequately evaluate the differences in cardiac reserve and cardiac efficiency.
Detailed description
Untreated hypertension decreases the cardiac reserve through several mechanisms, which are augmented by other cardiovascular risk factors such as diabetes mellitus and coronary artery disease. Perioperative stress on top of these overlapping diseases causes wide variations in the arterial blood pressure. From the anesthesiologist's point of view, this translates into a wide variation in response to surgical stress among patients with seemingly similar cardiovascular risk factors.
The cardiac reserve may be measured by cardiac catheterization or echocardiography, none of which are feasible during a surgery. Recently, some parameters of the Pressure Recording Analytical Method (PRAM) were shown to be affected by hypertension or intraoperative events such as pneumoperitoneum and position changes. This suggests that PRAM may be used to evaluate the risk of adverse hemodynamic events in newly diagnosed, untreated hypertensive patients.
The investigators hypothesized that there is a relationship between hypertension, diabetes mellitus and decreased cardiac reserve and efficiency and that PRAM parameters may identify this. Also, the static or dynamic PRAM parameters may predict pre-incision hypotension in patients wo will undergo major surgical procedures.
In order to test these hypothesis, a prospective cohort study was planned, as the outcome has a very short latency and the intent is to observe the outcome, not to prevent or treat it. The investigators aim to collect high quality hemodynamic data from normotensive, hypertensive, and untreated hypertensive patients. In order to obtain sufficient relevant data, only patients scheduled for major surgeries will be included. Patients who are planned to be monitored with the MostCare hemodynamic monitor, and who need a passive leg raising test will be included in the study.
Hypertension is the most prevalent of cardiovascular risk factors, namely diabetes mellitus, coronary artery disease, smoking, obesity, and dyslipidemia, which may present as either the mediator or cofounder of hypertension. Therefore a detailed medical history including information relevant to these conditions will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low cardiac reserve/efficiency | – | Diagnostic Test: Passive leg raisingPatients who were identified as having low cardiac reserve and efficiency, based on PRAM parameters. |
| Normal cardiac reserve/efficiency | – | Diagnostic Test: Passive leg raisingPatients who were identified as having normal cardiac reserve and efficiency, based on PRAM parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for any major surgery will be included. Major surgery includes a broad list of cardiac surgery, thoracic surgery, hepatic surgery, pancreatic surgery, colorectal surgery, major orthopedic surgeries, cancer surgeries, where blood loss or intravascular volume loss is expected due to factors related to the patient or surgery.
Key inclusion criteria (8 listed)
- Age at least 18 years
- Undergoing major surgery under general anesthesia
- Expected surgery time >2 h
- Expected length of postoperative stay >2 d
- Invasive blood pressure (radial or femoral) and Mostcare monitoring
Key exclusion criteria (16 listed)
- Refuse to consent to the study
- Arterial wave form distortion
- Cardiac arrhythmia
- Inappropriate identification of the dicrotic notch for any reason
- Planned intraoperative mean arterial blood pressure < 65 mmHg
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 |
|---|---|---|
| Passive leg raisingAll patients who met the inclusion criteria will be placed head down flat and feet up at a 45° angle for 30 seconds. Hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected before, during and after the test until the end of the surgery. The total duration of the intervention (passive leg raising) is 30 seconds. The total duration of hemodynamic parameters recording is expected to be 60-600 minutes. | Diagnostic test | Low cardiac reserve/efficiency, Normal cardiac reserve/efficiency |
Primary outcome
Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus
Time frame: From the start of surgery until the end of surgery
Difference in baseline PRAM parameters between patients who have hypertension, diabetes mellitus and other cardiovascular diseases and those who have none.
Difference of mean CCE, dP/dt, SVI, CPI, Ea at the 30th second of passive leg raising by hypertension and diabetes mellitus
Time frame: From the start of passive leg raising test until the end of the test
Difference in the magnitude of the changes observed in PRAM parameters after a passive leg raising test between patients who have hypertension, diabetes mellitus and other cardiovascular diseases and those who have none.
4 secondary outcomes
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Within 5 Minutes Following Tracheal Intubation
Time frame: From the start of surgery until the end of surgery
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Between Tracheal Intubation and Surgical Incision
Time frame: From the start of surgery until the end of surgery
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg During the Surgery
Time frame: From the start of surgery until the end of surgery
Predictive factors of hypotension
Time frame: From the start of surgery until the end of surgery
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 9 Apr 2025.
- Results publication: PubMed 34615363Choudhry NK, Kronish IM, Vongpatanasin W, Ferdinand KC, Pavlik VN, Egan BM, Schoenthaler A, Houston Miller N, Hyman DJ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology. Medication Adherence and Blood Pressure Control: A Scientific Statement From the American Heart Association. Hypertension. 2022 Jan;79(1):e1-e14. doi: 10.1161/HYP.0000000000000203. Epub 2021 Oct 7.
- Results publication: PubMed 30920917Burnier M, Egan BM. Adherence in Hypertension. Circ Res. 2019 Mar 29;124(7):1124-1140. doi: 10.1161/CIRCRESAHA.118.313220.
- Results publication: PubMed 28974066Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
- Results publication: PubMed 36267641Zhang H, Gao H, Xiang Y, Li J. Maximum inferior vena cava diameter predicts post-induction hypotension in hypertensive patients undergoing non-cardiac surgery under general anesthesia: A prospective cohort study. Front Cardiovasc Med. 2022 Oct 4;9:958259. doi: 10.3389/fcvm.2022.958259. eCollection 2022.
- Results publication: PubMed 18617626Chantler PD, Lakatta EG, Najjar SS. Arterial-ventricular coupling: mechanistic insights into cardiovascular performance at rest and during exercise. J Appl Physiol (1985). 2008 Oct;105(4):1342-51. doi: 10.1152/japplphysiol.90600.2008. Epub 2008 Jul 10.
- Results publication: PubMed 17936156Borlaug BA, Melenovsky V, Redfield MM, Kessler K, Chang HJ, Abraham TP, Kass DA. Impact of arterial load and loading sequence on left ventricular tissue velocities in humans. J Am Coll Cardiol. 2007 Oct 16;50(16):1570-7. doi: 10.1016/j.jacc.2007.07.032. Epub 2007 Oct 1.
- Results publication: PubMed 30859669Ikonomidis I, Aboyans V, Blacher J, Brodmann M, Brutsaert DL, Chirinos JA, De Carlo M, Delgado V, Lancellotti P, Lekakis J, Mohty D, Nihoyannopoulos P, Parissis J, Rizzoni D, Ruschitzka F, Seferovic P, Stabile E, Tousoulis D, Vinereanu D, Vlachopoulos C, Vlastos D, Xaplanteris P, Zimlichman R, Metra M. The role of ventricular-arterial coupling in cardiac disease and heart failure: assessment, clinical implications and therapeutic interventions. A consensus document of the European Society of Cardiology Working Group on Aorta & Peripheral Vascular Diseases, European Association of Cardiovascular Imaging, and Heart Failure Association. Eur J Heart Fail. 2019 Apr;21(4):402-424. doi: 10.1002/ejhf.1436. Epub 2019 Mar 12.
- Results publication: PubMed 22622108Kuznetsova T, D'hooge J, Kloch-Badelek M, Sakiewicz W, Thijs L, Staessen JA. Impact of hypertension on ventricular-arterial coupling and regional myocardial work at rest and during isometric exercise. J Am Soc Echocardiogr. 2012 Aug;25(8):882-90. doi: 10.1016/j.echo.2012.04.018. Epub 2012 May 22.
- Results publication: PubMed 22963833Lam CS, Shah AM, Borlaug BA, Cheng S, Verma A, Izzo J, Oparil S, Aurigemma GP, Thomas JD, Pitt B, Zile MR, Solomon SD. Effect of antihypertensive therapy on ventricular-arterial mechanics, coupling, and efficiency. Eur Heart J. 2013 Mar;34(9):676-83. doi: 10.1093/eurheartj/ehs299. Epub 2012 Sep 10.
- Results publication: PubMed 29019850Guinot PG, Longrois D, Kamel S, Lorne E, Dupont H. Ventriculo-Arterial Coupling Analysis Predicts the Hemodynamic Response to Norepinephrine in Hypotensive Postoperative Patients: A Prospective Observational Study. Crit Care Med. 2018 Jan;46(1):e17-e25. doi: 10.1097/CCM.0000000000002772.
- Results publication: PubMed 30422317Ikonomidis I, Katsanos S, Triantafyllidi H, Parissis J, Tzortzis S, Pavlidis G, Trivilou P, Makavos G, Varoudi M, Frogoudaki A, Vrettou AR, Vlastos D, Lekakis J, Iliodromitis E. Pulse wave velocity to global longitudinal strain ratio in hypertension. Eur J Clin Invest. 2019 Feb;49(2):e13049. doi: 10.1111/eci.13049. Epub 2018 Dec 19.
- Results publication: PubMed 22197117Romano SM. Cardiac cycle efficiency: a new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J Cardiol. 2012 Mar 8;155(2):326-7. doi: 10.1016/j.ijcard.2011.12.008. Epub 2011 Dec 22. No abstract available.
- Individual participant dataSharing planned: Undecided. The Ethics Committee's approval is required to make individual participant data available to other researchers.
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Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
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.
Fevzi Toraman, Prof. study director
Acibadem University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Surgery, run by Recep Tayyip Erdogan University at 5 sites in Turkey (Türkiye).
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 8 inclusion and 16 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 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). 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 Başar Erdivanlı, Assoc. Prof. (+90-505-7800730, basar.erdivanli@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus (time frame: From the start of surgery until the end of surgery). The study lists 2 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 NCT05960604, which also lists 19 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 9 Apr 2025.