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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, RM) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2027 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT06984302 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
- Study coordinator: Andrea Russo, medical doctor
- Email: andrea.russo@policlinicogemelli.it
- Phone: +39-0630153160
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery
This study tests how blood pressure, heart rate, and oxygen levels change during bimaxillary orthognathic surgery and whether the trigeminocardiac reflex occurs.
-
Sedation with dexmedetomidine, propofol, or both during cataract surgery
This project will test whether dexmedetomidine, propofol, or their combination (each given with fentanyl) provides the best sedation, safety, and surgeon satisfaction for adults having cataract surgery.
-
MRI-derived Pressure Ratio (MPR) to predict stroke risk in intracranial atherosclerosis (ICAS)
This study will test whether a new MRI-derived pressure ratio (MPR) can help predict 1-year stroke risk in adults (18–80) with 50–99% intracranial atherosclerotic stenosis in the anterior circulation.
-
Using a suprasternal ultrasound to see if heart filling changes help guide fluids in kids undergoing surgery
This observational study tests whether measuring aortic flow with a suprasternal Doppler can predict which pediatric patients will benefit from fluid adjustments during surgery.
-
Three goal-directed hemodynamic strategies for fluid management during major abdominal cancer surgery
This trial tests whether three goal-directed fluid-management approaches (FLOTRAC, the Hypotension Prediction Index, and HPI combined with Assisted Fluid Management) help people aged 65 and older having major abdominal cancer surgery keep blood pressure stable and reduce complications.
-
Investigating fluid responsiveness and venous congestion in critically ill patients during volume expansion
This study is testing how well critically ill patients respond to extra fluids and if they have too much fluid in their veins during treatment in the ICU.
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.