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Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients

ClinicalTrials.gov IDNCT05960604

PhaseNot Applicable

Enrollment660

SponsorRecep Tayyip Erdogan University

Age18 Years

SexALL

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Conditions studied

Cardiovascular Diseases, Surgery, Hypotension, Hypotension on Induction, Hypotension During Surgery

About this study

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.

Interventions

Diagnostic Test: 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.

Primary outcomes

Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus (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 (From the start of passive leg raising test until the end of the test)

Eligibility information

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Study locations

Gazi University Medical Faculty, Department of Anesthesiology and Reanimation, Ankara, 06560 Turkey (Türkiye)
Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation, Erzurum, 25240 Turkey (Türkiye)
Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic, Istanbul, 34480 Turkey (Türkiye)
Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, 34755 Turkey (Türkiye)
Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation, Rize, 53100 Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.