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

Not Applicable

Recruiting

• Conditions: Hemodynamic Instability
• Interventions: Other: Oxygen consumption optimization

• Registration Number: NCT03113435
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-13
• Study Start: 2018-06-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen consumption group	Oxygen consumption optimization	In this arm patients will receive hemodynamic optimization based on their oxygen consumption need
NICE group	Oxygen consumption optimization	In this arm patients will be treated according to stroke volume optimization described in NICE program

Primary Outcome Measures

Name	Time	Method
Perioperative fluid balance	surgery	Perioperative fluid balance

Secondary Outcome Measures

Name	Time	Method
Post-operative complication	1 day (Hospital discharge)	Increase in TnI, need for mechanical ventilation, infection, ICU admission, anastomotic leak, bleeding, AKI
Survival at 28 days	28 days after surgery	Patients who survived at 28 days
Survival at hospital discharge	1 day (Hospital discharge)	Patient who survived at hospital discharge

Trial Locations

Locations (1)

Fondazione Policlinico A. Gemelli IRCCS; 🇮🇹 Roma, Italy