Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06247384

The Hypotension Prediction Index in Major Abdominal Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypotension During Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The fundamental aspect of the anesthetics perioperative management is to maintain hemodynamic stability, with special attention on the avoidance or reduction of the episodes of intraoperative hypotension (IOH). The incidence of intraoperative hypotension is related to an increased rate of perioperative morbidity and mortality. Even a short period of hypotension can be related to an increased risk of postoperative stroke, myocardial injury and acute kidney injury. Patients undergoing major abdominal surgery are at a high-risk of IOH because such surgeries typically require more than 2h to complete and require blood transfusion or inotrope administration. Hemodynamic monitoring and the use of goal directed therapy protocols helps to diminish the incidence of perioperative complications, however the hypotension management remains a reactive approach, an intervention is made when the hypotension has already occured. The Hypotension Prediction Index is an machine learning algorithm which allows to predict the episodes of hypotension and intervene before mean arterial pressure drops below 65 mmHg. The aim of the current study is to compare the rate of hypotension in patients undergoing major abdominal surgery with the arterial pressure cardiac output algorithm and the hypotension prediction index algorithm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypotension Prediction Index Hemodynamic Monitoring

Device

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

Primary outcomes

  1. Time weighed average of hypotension below 65 mmHg

    Time frame: "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

Secondary outcomes

  1. Time weighed average of hypotension below 50 mmHg

    Time frame: "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 MAP of 50 mmHg x time in minutes spent below MAP of 50 mmHg)/total duration of operation in minutes

  2. Time weighed average of hypertension above 90 mmHg

    Time frame: "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

    rise of hypertension in millimetres of mercury above a MAP of 90 mmHg x time in minutes spent above MAP of 90 mmHg)/total duration of operation in minutes

  3. Time weighed average of hypertension above 100 mmHg

    Time frame: "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

    rise of hypertension in millimetres of mercury above MAP of 100 mmHg x time in minutes spent above MAP of 100 mmHg)/total duration of operation in minutes

  4. 30 day mortality

    Time frame: 30 consecutive days starting from the day of the surgery

    30 day mortality

  5. Length of hospitalisation

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

    Length of hospitalisation

  6. Myocardial injury evaluated by postoperative troponin levels

    Time frame: First, second and fifth postoperative day

    Myocardial injury evaluated by postoperative troponin levels

  7. Kidney injury evaluated by creatinine levels

    Time frame: First, second and fifth postoperative day

    Kidney injury evaluated by creatinine levels (increase in sCr by ≥0.3 mg/dL within 48 hours; increase in sCr to 1.5 times baseline; or urine volume less than 0.5 mL/kg/h for 6 hours)

  8. Intraoperative fluid dose

    Time frame: "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

    Intraoperative fluid administration

  9. Intraoperative vasopressor dose

    Time frame: "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

    Intraoperative vasopressor dose

  10. Rate of intra and postoperative atrial fibrillation

    Time frame: "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

    the occurrence of atrial fibrillation in the intraoperative and postoperative period up to 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Agata Gradys, Ph.D.

CONTACT

[email protected]

+48618691856

Jakub Szrama, Ph.D.

CONTACT

[email protected]

+48602170037

Sponsors and collaborators

Lead sponsor

Jakub Szrama

Other

Registry information

Official study title

The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.