Actively Recruiting
Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-11
76
Participants Needed
1
Research Sites
447 weeks
Total Duration
On this page
Sponsors
F
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
F
Flavia Torrini
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. In addition, excessive fluid administration has been related to worse post-operative outcomes. We divide patients into three groups: the standard treatment group, the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2 as marker of tissue ability to increase their oxygen consumption in response to increased O2 delivery, and based on this index the administration of fluid. The principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.
CONDITIONS
Official Title
Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged > 18 years
- Written informed consent obtained
- Undergoing major abdominal surgery including major gastrointestinal surgery (DCP, gastrectomy, Miles, emicolectomy) or gynecologic oncologic surgery
- Surgery duration of 3 hours or longer
You will not qualify if you...
- Absolute contraindication for central venous catheter (CVC) placement
- Pregnant women
- Undergoing hepatic surgery
- Undergoing laparoscopic surgery
- Undergoing major vascular surgery
- Receiving dialysis treatment or undergoing kidney transplant surgery
- Severe heart failure with ejection fraction ≤ 35%
- Emergency surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico A. Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
Research Team
A
Antonio M Dell'Anna, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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