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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2024

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: Standard
    • In this group standard care will be provided to patients undergoing major abdominal surgery, regarding hemodynamic optimization
  • Active Comparator: NICE group
    • In this arm patients will be treated according to stroke volume optimization described in NICE program
  • Experimental: Oxygen consumption group
    • In this arm patients will receive hemodynamic optimization based on their oxygen consumption need

Clinical Trial Outcome Measures

Primary Measures

  • Perioperative fluid balance
    • Time Frame: surgery
    • Perioperative fluid balance

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Collaborator
    • Flavia Torrini
  • Provider of Information About this Clinical Study
    • Principal Investigator: Antonio Maria Dell’Anna, MD – Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Overall Official(s)
    • Antonio M Dell’Anna, MD, Principal Investigator, Fondazione Policlinico Universitario A. Gemelli
  • Overall Contact(s)
    • Antonio M Dell’Anna, MD, +390630154490, anthosdel@yahoo.it

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