Actively Recruiting

Age: 18Years +
All Genders
NCT05960604

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

Led by Recep Tayyip Erdogan University · Updated on 2025-04-09

660

Participants Needed

5

Research Sites

171 weeks

Total Duration

On this page

Sponsors

R

Recep Tayyip Erdogan University

Lead Sponsor

T

Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at least 18 years
  • Undergoing major surgery under general anesthesia
  • Expected surgery time >2 hours
  • Expected length of postoperative stay >2 days
  • Monitoring with invasive blood pressure (radial or femoral) and MostCare
  • Indication for passive leg raising test due to risk of low blood volume or expected major surgery
  • Ability to read, understand, and ask questions about study information before surgery
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Refusal to consent to the study
  • Distorted arterial waveforms
  • Cardiac arrhythmia
  • Inability to correctly identify dicrotic notch
  • Planned mean arterial blood pressure below 65 mmHg during surgery
  • Hemodynamic instability with mean arterial blood pressure below 65 mmHg
  • Preoperative need for inotrope or vasopressor infusion
  • Use of vasoactive drugs before surgery
  • Intra-aortic balloon pump or extracorporeal membrane oxygenation support
  • Critically ill requiring ICU care before surgery
  • Presence of increased pressure inside the abdomen
  • Severe heart failure (NYHA Class 3-4)
  • Heart failure with ejection fraction less than 35%
  • Glomerular filtration rate below 30 ml/min/1.73 m2
  • Receiving ongoing renal replacement therapy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Gazi University Medical Faculty, Department of Anesthesiology and Reanimation

Ankara, Turkey (Türkiye), 06560

Actively Recruiting

2

Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation

Erzurum, Turkey (Türkiye), 25240

Actively Recruiting

3

Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic

Istanbul, Turkey (Türkiye), 34480

Actively Recruiting

4

Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation

Istanbul, Turkey (Türkiye), 34755

Actively Recruiting

5

Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation

Rize, Turkey (Türkiye), 53100

Not Yet Recruiting

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Research Team

B

Başar Erdivanlı, Assoc. Prof.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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