Effects of a Goal-directed Hemodynamic Therapy Driven by ECOM on Morbidity and Mortality After Cardiac Surgery?

Phase 4

Completed

• Conditions: Coronary Surgery With Cardiopulmonary Bypass
• Interventions: Behavioral: hemodynamic optimization strategy driven by the ECOM; Behavioral: standard management strategy

• Registration Number: NCT01535716
• Lead Sponsor: University Hospital, Caen

Brief Summary

Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic optimizations are more efficient when based on the dynamic parameters than when based on the statics ones, and the major dynamic criteria is the cardiac output. Unfortunately, transpulmonary thermodilution, the device considered as "The gold standard" to evaluate cardiac output is associated with many complications.Furthermore, devices commercialized in the past decade were not able to replace the transpulmonary thermodilution.

As all monitoring devices aren't reliable enough to be widely used in practice they are left aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on the analysis of several clinical parameters seems to guarantee good cares thanks to a favorable benefits/risks balance, it could be improved by new plug and play mini-invasive systems.

In the investigators opinion, the ECOM system seems able to provide a monitoring tool which responds to all the expectations of a modern hemodynamic monitoring device. It uses a well known technique, the bioimpedance. The investigators suppose this device should be more efficient than the one that has been used before. Indeed, as the system is build on the endotracheal tube, it comes closer to the aorta, where all the measures are made, and the recorded signal should be less affected by the passage through the surrounding tissues.

This randomized and controlled trial will study Patients scheduled for elective coronary surgery with cardiopulmonary bypass.

The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed hemodynamic therapy based on the ECOM cardiac output measure on mortality and major postoperative cardiac morbidity after coronary surgery, when compared with a standard management strategy.

Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard management strategy, applied to the control group, will be set and led by the attending anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and stroke volume variation.

The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure will reduce mortality and morbidity after cardiac surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-20
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-16
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Any man or woman
• Over 18 year-old
• After obtaining written informed consent
• Scheduled for elective coronary surgery with CPB

Exclusion Criteria

• Emergency surgery (< 24h)
• Combined cardiac surgery
• Patients < 18 years-old and/or unable to give informed consent
• Patients who refuse to give informed consent
• Pregnancy
• PVC allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ECOM group	hemodynamic optimization strategy driven by the ECOM	50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass
standard management group	standard management strategy	50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
length of hospital stay	Data collected at the exit of hospital or at death, if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days. expected before 1 month

Secondary Outcome Measures

Name	Time	Method
Number of major adverse cardiac events during stay in hospital	Data collected at the exit of ICU, at the exit of hospital or at death if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days.Up to 1 month
Length of stay in ICU	at the exit of ICU or at death, if during hospital stay.expected before 1 month
In-hospital mortality	at the end of the study. up to 12 month
Number of patients with Major adverse cardiac events during in-hospital stay.	at the end of the study. Up to 12 month

Trial Locations

Locations (1)

University Hospital of Caen; 🇫🇷 Caen, Calvados, France