Actively Recruiting
Hypotension Prediction Index for Hemodynamic Optimization in Major Vascular Surgery
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-07-31
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a predictive algorithm called the hypotension prediction index to optimize hemodynamic management during major vascular surgery, specifically abdominal aortic aneurysm repair. The study aims to compare this new method with standard cardiovascular parameter-based care to understand if it can better manage blood pressure during surgery. The trial is led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and uses a randomized, single-masked design. Participants are divided into two groups: the control group receives hemodynamic optimization based on standard cardiovascular parameters displayed on the Hemosphere platform, with drugs and fluids administered according to mean arterial pressure and stroke volume variation. The experimental group is managed using the hypotension prediction index to guide drug and fluid administration proactively. This study focuses on the intraoperative period during aortic surgery. During the surgery, researchers will monitor blood pressure and calculate the time-weighted average of mean arterial pressure below 65 mmHg as the primary outcome. Participants undergo continuous hemodynamic monitoring to assess the effectiveness of both approaches. The trial continues until the end of surgery, with no mention of extended follow-up periods. The total duration for participants is limited to the surgical procedure timeframe.
CONDITIONS
Brief Title
A PREDICTIVE ALGORITHM IN AORTIC SURGERY
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned aortic surgery
- Acceptance of written informed consent
You will not qualify if you...
- Body mass index over 35 kg/m2
- Atrial fibrillation
- Urgent surgery
- End-stage renal disease
- Pregnancy
- Refusal of consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Duration of surgery and immediate post-operative period
Participants undergo planned aortic surgery and receive hemodynamic management either by a predictive algorithm or standard care during surgery.
1 visit (in-person) on surgery day
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli
Rome, RM, Italy, 00148
Actively Recruiting
Research Team
A
Andrea Russo, medical doctor
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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