Optimizing oxygen consumption during major abdominal surgery
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
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT03113435
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Roma) |
| Trial ID | NCT03113435 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for major abdominal surgeries lasting three hours or more.
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.
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 performed: Other studies have shown promise in optimizing hemodynamic management during surgery, suggesting that this approach may yield beneficial results.
Eligibility criteria
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 this trial is running
Roma
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemodynamic Instability, CO2 gap, oxygen consumption, Stroke volume optimization