Ireland
--:--IST
Recruiting Not applicable

The Hypotension Prediction Index in Major Abdominal Surgery

NCT06247384 · tracked via the Priya Life Science Poland tracker
Sponsor
Jakub Szrama
Phase
Not applicable
Started
2025-01-01
Last updated
2025-08-03

Condition(s) studied

Hypotension During Surgery

Investigational drug(s) / intervention(s)

Hypotension Prediction Index Hemodynamic Monitoring

Hypotension Prediction Index Hemodynamic Monitoring: The application of the perioperative hemodynamic management according to the hypotension prediction index algorithm.

Study summary

The goal of this randomized clinical trial is to compare different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery.

Participants undergoing major abdominal surgery will receive anesthesia with two different types of hemodynamic monitoring - group A will receive arterial pressure cardiac output algorithm with the FloTrac sensor and group B will receive hemodynamic monitoring with the Hypotension Prediction Index.

The main question the study aims to answer is:

• will the hypotension prediction index algorithm reduce the rate of hypotension in comparison to arterial pressure cardiac output algorithm.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients qualified for elective major abdominal surgery, defined as an expected duration of more than two hours, an estimated blood loss of \>15% of blood volume, or an expected transfusion requirement of at least two packed red blood cells with general or combined anaesthesia. * Patients with American Society of Anesthesiologists (ASA) status III or IV. * Written informed consent. Exclusion Criteria: * Patients under 18 years * Lack of health insurance * Pregnancy * Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction \< 35 % * Persistent atrial fibrillation and other arrhythmias impairing arterial pressure cardiac output monitoring

Primary outcome measure(s)

  • Time weighed average of hypotension below 65 mmHg — "From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days
    depth of hypotension in millimetres of mercury below a mean arterial pressure (MAP) of 65 mmHg x time in minutes spent below MAP of 65mmHg)/total duration of operation in minutes

Trial sites (1)

FacilityCityRegionStatus
Department of Anesthesiology, Intensive Therapy and Pain Management Poznan Poznań Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06247384 on ClinicalTrials.gov ↗ ← All trials in Poland