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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Hemodynamic Instability

Treatments: Other: Oxygen consumption optimization

Study type: Interventional

Funder types: Other

Identifiers

NCT03113435

1305

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 3 patient groups

Standard

No Intervention group

Description:

In this group standard care will be provided to patients undergoing major abdominal surgery, regarding hemodynamic optimization

NICE group

Active Comparator group

Description:

In this arm patients will be treated according to stroke volume optimization described in NICE program

Treatment:

Other: Oxygen consumption optimization

Oxygen consumption group

Experimental group

Description:

In this arm patients will receive hemodynamic optimization based on their oxygen consumption need

Treatment:

Other: Oxygen consumption optimization