Clinical trial NCT06247384: The Hypotension Prediction Index in Major Abdominal Surgery
Official title: The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypotension During Surgery
Keywords: hypotension prediction index
major abdominal surgery
arterial pressure cardiac output
intraoperative hypotension
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time weighed average of hypotension below 65 mmHg
timeFrame: "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:
measure: Time weighed average of hypotension below 50 mmHg
timeFrame: "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
measure: Time weighed average of hypertension above 90 mmHg
timeFrame: "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
measure: Time weighed average of hypertension above 100 mmHg
timeFrame: "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
measure: 30 day mortality
timeFrame: 30 consecutive days starting from the day of the surgery
measure: Length of hospitalisation
timeFrame: From the date of randomisation to the date of hospital discharge or death, whichever comes first, assessed up to 30 days
measure: Myocardial injury evaluated by postoperative troponin levels
timeFrame: First, second and fifth postoperative day
measure: Kidney injury evaluated by creatinine levels
timeFrame: First, second and fifth postoperative day
measure: Intraoperative fluid dose
timeFrame: "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
measure: Intraoperative vasopressor dose
timeFrame: "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
measure: Rate of intra and postoperative atrial fibrillation
timeFrame: "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
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Anesthesiology, Intensive Therapy and Pain Management
Study officials:
affiliation: Poznan Univeristy of Medical Sciences, Department of Anesthesiology, Intensive Therapy and Pain Management
name: Krzysztof Kusza, Prof.
role: STUDY_CHAIR
References: