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Recruiting Not applicable

Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach

NCT03113435 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2018-06-01
Last updated
2025-03-11

Condition(s) studied

Hemodynamic Instability

Investigational drug(s) / intervention(s)

Oxygen consumption optimization

Oxygen consumption optimization: hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Perioperative fluid balance — surgery
    Perioperative fluid balance

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico A. Gemelli IRCCS Roma Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03113435 on ClinicalTrials.gov ↗ ← All trials in Italy