The Hypotension Prediction Index in Major Abdominal Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypotension During Surgery
• Intervention / Treatment: Device: Hypotension Prediction Index Hemodynamic Monitoring

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakub Szrama, Ph.D.; Phone Number: +48602170037; Email: jakub.szrama@usk.poznan.pl
• Study Contact Backup: Name: Agata Gradys, Ph.D.; Phone Number: +48618691856; Email: agata.gradys@usk.poznan.pl

Study Locations

• Poland
  • Poznań, Poland, 60-355
    • Department of Anesthesiology, Intensive Therapy and Pain Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A - FloTrac group; Patients receiving standard therapy with the arterial pressure cardiac output hemodynamic monitoring
Experimental: Group B - HPI - Hypotension Prediction Index group; Patients receiving therapy according to the hypotension prediction index hemodynamic monitoring.	Device: Hypotension Prediction Index Hemodynamic Monitoring; The application of the perioperative hemodynamic management according to the hypotension prediction index algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time weighed average of hypotension below 50 mmHg	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	"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 day mortality	30 consecutive days starting from the day of the surgery
Length of hospitalisation	Length of hospitalisation	From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days
Myocardial injury evaluated by postoperative troponin levels	Myocardial injury evaluated by postoperative troponin levels	First postoperative day
Kidney injury evaluated by creatinine levels	Kidney injury evaluated by creatinine levels	First postoperative day
Intraoperative fluid dose	Intraoperative fluid administration	"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	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

Collaborators and Investigators

• Sponsor: Jakub Szrama
• Investigators: Study Chair: Krzysztof Kusza, Prof., Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy and Pain Management

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: major abdominal surgery; intraoperative hypotension; hypotension prediction index; arterial pressure cardiac output
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: PoznanUMSHPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No