Optimizing oxygen consumption during major abdominal surgery
Official title: Patient Management During Major Abdominal Surgery: the Impact of a Hemodynamic Approach Oriented to Oxygen Consumption Optimization Compared to Standard Approach Targeting Preload-dependency and a Clinically-guided Strategy
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT03113435 · Data updated 2026-11-12
This study tests a new way to manage fluid levels during major abdominal surgery to see if it helps patients recover better compared to the usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | June 1, 2018 |
| Main results expected | July 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 11, 2025 |
| Trial ID | NCT03113435 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old scheduled for major abdominal surgeries lasting three hours or more.
✕Probably not a fit
Patients with severe heart failure, those undergoing emergency surgeries, or those with contraindications to central venous catheter placement may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares a new protocol for hemodynamic optimization during major abdominal surgery against the standard care approach. It focuses on tailoring fluid administration based on the body's actual metabolic needs during general anesthesia, aiming to reduce excessive fluid intake that can lead to worse post-operative outcomes. Patients will be divided into three groups: standard treatment, NICE protocol, and an intervention group that uses a specific marker to guide fluid administration. The goal is to enhance functional hemodynamics and minimize fluid balance at the end of surgery.
Why it matters
Potential benefit: If successful, this approach could lead to improved post-operative outcomes and reduced complications for patients undergoing major abdominal surgery.
How similar studies have gone: Other studies have shown promise in optimizing hemodynamic management during surgery, suggesting that this approach may yield beneficial results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients aged \> 18 years * acquisition of written informed consent * Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours Exclusion Criteria: * Absolute contraindication to CVC placement * pregnant women * hepatic surgery * laparoscopic surgery * Major vascular surgery * Dialysis treatment and kidney transplant surgery * Severe heart failure (EF ≤ 35%) * Emergency surgery
Where it's running
-
Fondazione Policlinico A. Gemelli IRCCS
Roma, Italy Recruiting
Study contacts
- Principal investigator: Antonio M Dell'Anna, MD — Fondazione Policlinico Universitario A. Gemelli
- Study coordinator: Antonio M Dell'Anna, MD
- Email: anthosdel@yahoo.it
- Phone: +390630154490
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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.