Clinical Trial

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

Study acronym: PRAM-in-HYPO
Recruiting
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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. 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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-07-17; most recent amendment 2025-04-08.
Status change: Not Yet Recruiting → Recruiting 2024-10-09
Trial Details
NCT Number NCT05960604
Lead Sponsor Recep Tayyip Erdogan University
Collaborators: Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care
Conditions Cardiovascular Diseases, Surgery, Hypotension, Hypotension on Induction, Hypotension During Surgery
Enrollment 660 participants
Start Date 2024-02-19
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-04-09