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

NCT ID: NCT01535716

Last Updated: 2013-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-02-28

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.

Conditions

Coronary Surgery With Cardiopulmonary Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ECOM group

50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass

Group Type: EXPERIMENTAL

hemodynamic optimization strategy driven by the ECOM

Intervention Type: BEHAVIORAL

goal directed hemodynamic therapy is based on the ECOM evaluation of stroke volume variation (SVV) & cardiac index (CI).

goals:

• SVV < 11%
• IC > 2,2 ml/min/m²

During the anesthesia

standard management group

50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass

Group Type: ACTIVE_COMPARATOR

standard management strategy

Intervention Type: BEHAVIORAL

goal directed hemodynamic therapy will be set and performed by the attending anesthetist, based on the analysis of further clinical parameters: Standard monitoring : heart rate, saturation index

• Diuresis > 0,5ml/kg/h
• Blood pressure , PAM > 65 mmHg
• Pulse pressure variation
• CVP 8 to 12 cmH20
• Visual aspect of the heart
• Overload signs During the anesthesia

Interventions

hemodynamic optimization strategy driven by the ECOM

goal directed hemodynamic therapy is based on the ECOM evaluation of stroke volume variation (SVV) & cardiac index (CI).

goals:

• SVV < 11%
• IC > 2,2 ml/min/m²

During the anesthesia

Intervention Type: BEHAVIORAL

standard management strategy

goal directed hemodynamic therapy will be set and performed by the attending anesthetist, based on the analysis of further clinical parameters: Standard monitoring : heart rate, saturation index

• Diuresis > 0,5ml/kg/h
• Blood pressure , PAM > 65 mmHg
• Pulse pressure variation
• CVP 8 to 12 cmH20
• Visual aspect of the heart
• Overload signs During the anesthesia

Intervention Type: BEHAVIORAL

Other Intervention Names

Endotracheal cardiac output monitoring

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CONMED Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Luc Fellahi

Role: STUDY_DIRECTOR

EA3212: groupe coeur et ischémie

Locations

University Hospital of Caen

Caen, Calvados, France

Countries

France

Other Identifiers

2011-A01210-41

Identifier Type: -

Identifier Source: org_study_id