Clinical trial NCT01535716: Effects of a Goal-directed Hemodynamic Therapy Driven by ECOM on Morbidity and Mortality After Cardiac Surgery?
Official title: Does Goal-directed Hemodynamic Therapy Driven by Endotracheal Cardiac Output Monitoring System During Surgical Intervention Reduce Hospital Stay and Major Adverse Cardiac Events Following Cardiac Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Surgery With Cardiopulmonary Bypass
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: CONMED Corporation
First posted: 2012-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: length of hospital stay
timeFrame: 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 outcomes:
measure: Number of major adverse cardiac events during stay in hospital
timeFrame: 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
measure: Length of stay in ICU
timeFrame: at the exit of ICU or at death, if during hospital stay.expected before 1 month
measure: In-hospital mortality
timeFrame: at the end of the study. up to 12 month
measure: Number of patients with Major adverse cardiac events during in-hospital stay.
timeFrame: at the end of the study. Up to 12 month
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital of Caen
state: Calvados
Study officials:
affiliation: EA3212: groupe coeur et ischémie
name: Jean-Luc Fellahi
role: STUDY_DIRECTOR
References: