The hypotension prediction index in major abdominal surgery - A prospective randomised clinical trial protocol.
Jakub Szrama, Agata Gradys, Zuzanna Nowak...
https://pubmed.ncbi.nlm.nih.gov/39895857Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06247384
The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.
Led by Jakub Szrama · Updated on 2025-08-03
226
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different types of advanced hemodynamic monitoring in patients undergoing major abdominal surgery to reduce episodes of low blood pressure during surgery. The study compares the Hypotension Prediction Index, a machine learning algorithm that predicts and helps prevent low blood pressure, with the arterial pressure cardiac output algorithm currently used in standard care. The aim is to see which method better reduces the rate of intraoperative hypotension, which is linked to serious complications like stroke, heart injury, and kidney damage. Participants will be randomly assigned to one of two groups during surgery. Group A receives monitoring with the arterial pressure cardiac output algorithm using the FloTrac sensor, which guides treatment after low blood pressure occurs. Group B receives monitoring guided by the Hypotension Prediction Index algorithm, which predicts hypotension before it happens to allow earlier intervention. The study collects data from the start of anesthesia until discharge from the post-anesthesia care unit. During the study, patients will have their blood pressure continuously monitored, and treatments will be adjusted based on their assigned monitoring method. Researchers will measure the time and severity of low blood pressure below 65 mmHg, as well as other outcomes such as very low blood pressure episodes, high blood pressure episodes, heart injury, kidney injury, hospital stay length, and complications up to 30 days after surgery. The study involves a single-blind design and includes patients aged 18 to 80 undergoing major abdominal surgery.
CONDITIONS
Brief Title
The Hypotension Prediction Index in Major Abdominal Surgery
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients qualified for elective major abdominal surgery expected to last more than two hours or with estimated blood loss over 15% of blood volume or requiring at least two packed red blood cell transfusions
- Patients with American Society of Anesthesiologists (ASA) status III or IV
- Written informed consent provided
You will not qualify if you...
- Patients under 18 years old
- Lack of health insurance
- Pregnancy
- Known congenital heart disease, severe aortic or mitral valve stenosis, heart failure with ejection fraction below 35%
- Persistent atrial fibrillation or other arrhythmias that impair arterial pressure cardiac output monitoring
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From induction to end of anesthesia (surgery duration typically more than 2 hours)
Participants undergo major abdominal surgery with hemodynamic monitoring using either the standard arterial pressure cardiac output algorithm or the hypotension prediction index algorithm during anesthesia.
1 surgery visit (in-person)
Post-operative Follow-up
Duration - Up to 30 days after surgery
Participants are monitored for postoperative outcomes including myocardial and kidney injury, and other complications up to 30 days after surgery.
3 visits on postoperative days 1, 2, and 5
Trial Site Locations
Total: 1 location
1
Department of Anesthesiology, Intensive Therapy and Pain Management
Poznan, Poznań, Poland, 60-355
Actively Recruiting
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Research Team
J
Jakub Szrama, Ph.D.
A
Agata Gradys, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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