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

Study acronym: PRAM-in-HYPO
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Jun 2026 to Jun 2027
    v5
  2. Notable Primary completion date: Feb 2025 to Dec 2025
    • Study completion date: Jun 2025 to Jun 2026
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Study sites: 2 to 5
    • Primary completion date: Oct 2024 to Feb 2025
    • Study completion date: Mar 2025 to Jun 2025
    • Start date changed from estimate of Dec 25, 2023 to Feb 19, 2024
    • Publications: 20 to 19
  4. Notable Lead sponsor: Rize Üniversitesi to Recep Tayyip Erdogan University
    • Start date: Oct 2023 to Dec 25, 2023
    • Collaborator revised
    • Study title expanded, about 5 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05960604
Lead Sponsor Recep Tayyip Erdogan University
Collaborators: Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care
Conditions
(from sponsor)
Cardiovascular Diseases, Surgery, Hypotension, Hypotension on Induction, Hypotension During Surgery
Related terms Cardiovascular Diseases, Hypotension
Enrollment 660 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov