Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06984302

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Planned aortic surgery
  • Acceptance of written informed consent
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Surgery and Immediate Post-operative Care

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

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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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