The Hypotension Prediction Index in Major Abdominal Surgery

Not Applicable

Not yet recruiting

• Conditions: Hypotension During Surgery

• Registration Number: NCT06247384
• Lead Sponsor: Jakub Szrama

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Study Start: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

• Patients qualified to major abdominal surgery
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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	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
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	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
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	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
30 day mortality	30 consecutive days starting from the day of the surgery	30 day mortality
Length of hospitalisation	From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days	Length of hospitalisation
Myocardial injury evaluated by postoperative troponin levels	First, second and fifth postoperative day	Myocardial injury evaluated by postoperative troponin levels
Kidney injury evaluated by creatinine levels	First, second and fifth postoperative day	Kidney injury evaluated by creatinine levels
Intraoperative fluid dose	"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
Intraoperative vasopressor dose	"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
Rate of intra and postoperative atrial fibrillation	"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

Trial Locations

Locations (1)

Department of Anesthesiology, Intensive Therapy and Pain Management; 🇵🇱 Poznań, Poland