The Hypotension Prediction Index in Major Abdominal Surgery

NCT06247384 | Recruiting DMC FDA Device

• 1 other identifier: PoznanUMSHPI
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension During Surgery

Keywords

hypotension prediction index; major abdominal surgery; arterial pressure cardiac output; intraoperative hypotension

Outcome Measures

Primary Outcomes (1)

• Time weighed average of hypotension below 65 mmHg

  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

  "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

Secondary Outcomes (10)

• Time weighed average of hypotension below 50 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

• Time weighed average of hypertension above 90 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

• Time weighed average of hypertension above 100 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

• 30 day mortality

  30 consecutive days starting from the day of the surgery

• Length of hospitalisation

  From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days

Study Arms (2)

Group A - FloTrac group

NO INTERVENTION

Patients receiving standard therapy with the arterial pressure cardiac output hemodynamic monitoring

Group B - HPI - Hypotension Prediction Index group

EXPERIMENTAL

Patients receiving therapy according to the hypotension prediction index hemodynamic monitoring.

Device: Hypotension Prediction Index Hemodynamic Monitoring

Interventions

Hypotension Prediction Index Hemodynamic Monitoring DEVICE

The application of the perioperative hemodynamic management according to the hypotension prediction index algorithm.

Group B - HPI - Hypotension Prediction Index group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jakub Szrama: lead

Study Sites (1)

Department of Anesthesiology, Intensive Therapy and Pain Management

Poznan, Poznań, 60-355, Poland

RECRUITING

Related Publications (1)

• Szrama J, Gradys A, Nowak Z, Lohani A, Zwolinski K, Bartkowiak T, Wozniak A, Koszel T, Kusza K. The hypotension prediction index in major abdominal surgery - A prospective randomised clinical trial protocol. Contemp Clin Trials Commun. 2024 Dec 28;43:101417. doi: 10.1016/j.conctc.2024.101417. eCollection 2025 Feb.

  PMID: 39895857 DERIVED

Study Officials

• Krzysztof Kusza, Prof.

  Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy and Pain Management

  STUDY CHAIR

Central Study Contacts

Jakub Szrama, Ph.D.

CONTACT

+48602170037; jakub.szrama@usk.poznan.pl

Agata Gradys, Ph.D.

CONTACT

+48618691856; agata.gradys@usk.poznan.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 7, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)