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

Hemodynamic Instability Clinical Trial

— HEART-CORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03113435
• Other study ID #: 1305
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Antonio M Dell'Anna, MD
• Phone: +390630154490
• Email: anthosdel[@]yahoo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico A. Gemelli IRCCS	Roma

Sponsors (10)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Alessandra Bisanti, Andrea Russo, Domenica Luca Grieco, Eleonora Filipponi, Flavia Torrini, Liliana Sollazzi, Massimo Antonelli, Pierpaolo Ciocchetti, Valter Perilli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative fluid balance	Perioperative fluid balance	surgery
Secondary	Survival at 28 days	Patients who survived at 28 days	28 days after surgery
Secondary	Survival at hospital discharge	Patient who survived at hospital discharge	1 day (Hospital discharge)
Secondary	Post-operative complication	Increase in TnI, need for mechanical ventilation, infection, ICU admission, anastomotic leak, bleeding, AKI	1 day (Hospital discharge)