Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients
NCT ID: NCT05960604
Last Updated: 2025-04-09
Study Results
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Basic Information
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RECRUITING
660 participants
OBSERVATIONAL
2024-02-19
2027-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Low cardiac reserve/efficiency
Patients who were identified as having low cardiac reserve and efficiency, based on PRAM parameters.
Passive leg raising
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.
Normal cardiac reserve/efficiency
Patients who were identified as having normal cardiac reserve and efficiency, based on PRAM parameters.
Passive leg raising
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.
Interventions
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Passive leg raising
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care
UNKNOWN
Recep Tayyip Erdogan University
OTHER
Responsible Party
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Başar Erdivanlı
Assoc. Prof. Başar Erdivanlı
Principal Investigators
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Fevzi Toraman, Prof.
Role: STUDY_DIRECTOR
Acibadem University
Locations
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Gazi University Medical Faculty, Department of Anesthesiology and Reanimation
Ankara, , Turkey (Türkiye)
Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation
Erzurum, , Turkey (Türkiye)
Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic
Istanbul, , Turkey (Türkiye)
Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation
Istanbul, , Turkey (Türkiye)
Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
Rize, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Burnier M, Egan BM. Adherence in Hypertension. Circ Res. 2019 Mar 29;124(7):1124-1140. doi: 10.1161/CIRCRESAHA.118.313220.
Sudfeld 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.
Zhang 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.
Chantler 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.
Borlaug 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.
Ikonomidis 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.
Kuznetsova 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.
Lam 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.
Guinot 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.
Ikonomidis 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.
Romano 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.
Sahiti 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.
Siripruekpong 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.
Salim 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.
Hojo T, Kimura Y, Shibuya M, Fujisawa T. Predictors of hypotension during anesthesia induction in patients with hypertension on medication: a retrospective observational study. BMC Anesthesiol. 2022 Nov 11;22(1):343. doi: 10.1186/s12871-022-01899-9.
Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
Jor O, Maca J, Koutna J, Gemrotova M, Vymazal T, Litschmannova M, Sevcik P, Reimer P, Mikulova V, Trlicova M, Cerny V. Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study. J Anesth. 2018 Oct;32(5):673-680. doi: 10.1007/s00540-018-2532-6. Epub 2018 Jul 19.
Other Identifiers
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PRAM-in-HYPO
Identifier Type: -
Identifier Source: org_study_id
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