Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach
Recruiting now · Not applicable
Conditions studied: Hemodynamic Instability
In brief
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.
Key facts
- Study ID
- NCT03113435
- Run by
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- People needed
- 76
- Starts
- 2018-06-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Fondazione Policlinico A. Gemelli IRCCS — Roma, Italy (enrolling)
Full record on ClinicalTrials.gov
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