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

This study has been completed.
Sponsor:
Collaborator:
ConMed Corporation
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01535716
First received: February 7, 2012
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Coronary Surgery With Cardiopulmonary Bypass
Behavioral: hemodynamic optimization strategy driven by the ECOM
Behavioral: standard management strategy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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?

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • length of hospital stay [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of major adverse cardiac events during stay in hospital [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Length of stay in ICU [ Time Frame: at the exit of ICU or at death, if during hospital stay.expected before 1 month ] [ Designated as safety issue: No ]
  • In-hospital mortality [ Time Frame: at the end of the study. up to 12 month ] [ Designated as safety issue: No ]
  • Number of patients with Major adverse cardiac events during in-hospital stay. [ Time Frame: at the end of the study. Up to 12 month ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECOM group
50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass
Behavioral: 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

Other Name: Endotracheal cardiac output monitoring
Active Comparator: standard management group
50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535716

Locations
France
University Hospital of Caen
Caen, Calvados, France, 14000
Sponsors and Collaborators
University Hospital, Caen
ConMed Corporation
Investigators
Study Director: Jean-Luc Fellahi EA3212: groupe coeur et ischémie
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01535716     History of Changes
Other Study ID Numbers: 2011-A01210-41
Study First Received: February 7, 2012
Last Updated: April 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on November 25, 2014