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

NCT01535716 | Completed Phase 4 DMC

• 1 other identifier: 2011-A01210-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

ECOM group

EXPERIMENTAL

50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass

Behavioral: hemodynamic optimization strategy driven by the ECOM

standard management group

ACTIVE COMPARATOR

50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass

Behavioral: standard management strategy

Interventions

hemodynamic optimization strategy driven by the ECOM 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

Also known as: Endotracheal cardiac output monitoring

ECOM group

standard management strategy 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

standard management group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead
• CONMED Corporation: collaborator

Study Sites (1)

University Hospital of Caen

Caen, Calvados, 14000, France

Location

Related Publications (1)

• Fellahi JL, Brossier D, Dechanet F, Fischer MO, Saplacan V, Gerard JL, Hanouz JL. Early goal-directed therapy based on endotracheal bioimpedance cardiography: a prospective, randomized controlled study in coronary surgery. J Clin Monit Comput. 2015 Jun;29(3):351-8. doi: 10.1007/s10877-014-9611-5. Epub 2014 Nov 9.

  PMID: 25380955 RESULT

Study Officials

• Jean-Luc Fellahi

  EA3212: groupe coeur et ischémie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 20, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 2, 2026

Record last verified: 2013-04

Locations

FR (1)