Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach (HEART-CORE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Other: Oxygen consumption optimization

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio M Dell'Anna, MD; Phone Number: +390630154490; Email: anthosdel@yahoo.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico A. Gemelli IRCCS
    • Contact: Antonio M Dell'Anna, MD; Phone Number: +390630154490; Email: antoniomaria.dellanna@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Oxygen consumption optimization; hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio
Experimental: Oxygen consumption group; In this arm patients will receive hemodynamic optimization based on their oxygen consumption need	Other: Oxygen consumption optimization; hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative fluid balance	Perioperative fluid balance	surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Collaborators: Massimo Antonelli; Flavia Torrini; Alessandra Bisanti; Eleonora Filipponi; Domenica Luca Grieco; Liliana Sollazzi; Valter Perilli; Andrea Russo; Pierpaolo Ciocchetti
• Investigators: Principal Investigator: Antonio M Dell'Anna, MD, Fondazione Policlinico Universitario A. Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: oxygen consumption; CO2 gap; Stroke volume optimization
• Other Study ID Numbers: 1305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No