The Hypotension Prediction Index in Major Abdominal Surgery

Hypotension During Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06247384
• Other study ID #: PoznanUMSHPI
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Poznan University of Medical Sciences
• Contact: Jakub Szrama, Ph.D.
• Phone: +48602170037
• Email: jakub.szrama[@]usk.poznan.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension During Surgery

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Anesthesiology, Intensive Therapy and Pain Management	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Jakub Szrama

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	30 day mortality	30 day mortality	30 consecutive days starting from the day of the surgery
Secondary	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
Secondary	Myocardial injury evaluated by postoperative troponin levels	Myocardial injury evaluated by postoperative troponin levels	First postoperative day
Secondary	Kidney injury evaluated by creatinine levels	Kidney injury evaluated by creatinine levels	First postoperative day
Secondary	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
Secondary	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