Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using a prediction algorithm to prevent low blood pressure during abdominal aortic aneurysm repair

Official title: HYPOTENSION PREDICTION INDEX FOR HEMODYNAMIC OPTIMIZATION IN MAJOR VASCULAR SURGERY

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06984302 · Data updated 2026-11-12

This trial will try whether using the Hemosphere platform's hypotension prediction index to guide hemodynamic therapy can reduce low blood pressure during abdominal aortic aneurysm repair.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations1 site (Rome, RM)
StatusRecruiting
StartedJune 1, 2025
Main results expectedJune 1, 2026
Study endsJune 1, 2027
Registry record updatedJuly 31, 2025
Trial IDNCT06984302 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults scheduled for elective abdominal aortic aneurysm repair who can give informed consent and do not have atrial fibrillation, BMI over 35 kg/m2, end-stage renal disease, pregnancy, or need for urgent surgery.

Probably not a fit

Patients with atrial fibrillation, BMI >35 kg/m2, end-stage renal disease, pregnancy, or those requiring urgent/emergent surgery are excluded and would not be expected to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial will enroll patients scheduled for elective abdominal aortic aneurysm repair and randomize them to two groups. The control arm will receive hemodynamic optimization based on standard cardiovascular parameters displayed on the Hemosphere platform. The interventional arm will use the Hypotension Prediction Index to prompt proactive therapy aimed at preventing hypotension. The study is conducted at a single center and will compare intraoperative hemodynamic stability and related outcomes between the two approaches.

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 organ injury and complications after aortic repair.

How similar studies have gone: Previous perioperative studies of the Hypotension Prediction Index have shown reductions in intraoperative hypotension in noncardiac surgeries, but evidence in major vascular procedures like aortic repair is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* planned aortic surgery acceptance of written informed consent

Exclusion Criteria:

* body mass index \> 35 kg/m2
* atrial fibrillation
* urgent surgery
* end-stage renal disease
* pregnancy
* refusal of the consent

Where it's running

  • Fondazione Policlinico Universitario Agostino Gemelli
    Rome, Rm, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.