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

HYPOTENSION PREDICTION INDEX FOR HEMODYNAMIC OPTIMIZATION IN MAJOR VASCULAR SURGERY

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

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Rome, RM)
• Trial ID: NCT06984302 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Rome, RM

• Fondazione Policlinico Universitario Agostino Gemelli — Rome, RM, Italy (RECRUITING)

Study contacts

• Study coordinator: Andrea Russo, medical doctor

Conditions: Hemodynamic