Using a hypotension prediction algorithm during major abdominal surgery
Official title: The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.
Run by Poznan University of Medical Sciences · NCT06247384 · Data updated 2026-11-12
This trial will test whether a machine-learning Hypotension Prediction Index versus arterial pressure cardiac output monitoring can reduce low blood pressure during major abdominal surgery in adults with higher surgical risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 226 (estimated) |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 1 site (Poznan, Poznań) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT06247384 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults eligible are those scheduled for elective major abdominal surgery expected to last over two hours or with anticipated significant blood loss/transfusion needs, with ASA physical status III or IV and able to give informed consent.
✕Probably not a fit
Patients with persistent atrial fibrillation or other arrhythmias, severe valvular disease, heart failure with ejection fraction below 35%, pregnant patients, minors, or those unable to have the required monitoring are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares two advanced intraoperative hemodynamic monitoring strategies in patients having elective major abdominal surgery: arterial pressure cardiac output monitoring with the FloTrac sensor versus the Hypotension Prediction Index (HPI) algorithm. Patients meeting inclusion criteria (expected surgery >2 hours or significant blood loss/transfusion needs and ASA III–IV) are randomized to one of the two monitoring approaches during anesthesia. The primary focus is whether use of the HPI can predict and prevent episodes of mean arterial pressure falling below 65 mmHg, compared with the reactive APCO-guided management. Outcomes include the rate and duration of intraoperative hypotension and related perioperative complications.
Why it matters
Potential benefit: If successful, using the Hypotension Prediction Index could reduce episodes of intraoperative low blood pressure and lower the risk of complications such as myocardial injury, stroke, and acute kidney injury.
How similar studies have gone: Prior randomized and observational studies of the Hypotension Prediction Index have shown reductions in intraoperative hypotension in some settings, but results have varied and are not uniformly conclusive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients qualified for elective major abdominal surgery, defined as an expected duration of more than two hours, an estimated blood loss of \>15% of blood volume, or an expected transfusion requirement of at least two packed red blood cells with general or combined anaesthesia. * Patients with American Society of Anesthesiologists (ASA) status III or IV. * 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
Where it's running
-
Department of Anesthesiology, Intensive Therapy and Pain Management
Poznan, Poznań, Poland Recruiting
Study contacts
- Study coordinator: Jakub Szrama, Ph.D.
- Email: jakub.szrama@usk.poznan.pl
- Phone: +48602170037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.