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NCT Number: NCT03113435

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

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.

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Key information

Conditions

Hemodynamic Instability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico A. Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

Antonio M Dell'Anna, MD

CONTACT

[email protected]

+390630154490

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen consumption optimization

Other

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

Primary outcomes

  1. Perioperative fluid balance

    Time frame: surgery

    Perioperative fluid balance

Secondary outcomes

  1. Survival at 28 days

    Time frame: 28 days after surgery

    Patients who survived at 28 days

  2. Survival at hospital discharge

    Time frame: 1 day (Hospital discharge)

    Patient who survived at hospital discharge

  3. Post-operative complication

    Time frame: 1 day (Hospital discharge)

    Increase in TnI, need for mechanical ventilation, infection, ICU admission, anastomotic leak, bleeding, AKI

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio M Dell'Anna, MD

CONTACT

[email protected]

+390630154490

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Alessandra Bisanti
  • Andrea Russo
  • Domenica Luca Grieco
  • Eleonora Filipponi
  • Flavia Torrini
  • Liliana Sollazzi
  • Massimo Antonelli
  • Pierpaolo Ciocchetti
  • Valter Perilli

Registry information

Official study 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

Acronym: HEART-CORE

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2017
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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