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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard

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

Group Type NO_INTERVENTION

No interventions assigned to this group

NICE group

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

Group Type ACTIVE_COMPARATOR

Oxygen consumption optimization

Intervention Type OTHER

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

Oxygen consumption group

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

Group Type EXPERIMENTAL

Oxygen consumption optimization

Intervention Type OTHER

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

Interventions

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Oxygen consumption optimization

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No