Study of Myocardial Contractility After Cardiac Surgery Under an Anterograde or Retrograde Cardioplegia

Sponsor
Brugmann University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02816385
Collaborator
(none)
20
1
2
14
1.4

Study Details

Study Description

Brief Summary

Myocardial protection is a fundamental element for the safety of patients when performing cardiac surgery. For this purpose, cardioplegia were rapidly established in clinical practice to protect the myocardium when performing aortic clamp.

Cardioplegia are procedures to stop the contraction of myocardium. It is usually achieved with the use of chemicals ( cardioplegic solutions) or cold temperature (such as chilled perfusate). The composition of the cardioplegic solutions and their method of administration continuously changed over the years.

At the present date, cold blood cardioplegias are performed in the investigator's center. The investigators regularly use two modes of administration: either by an antegrade path (injection in the coronary arteries), or a retrograde one (injection in the venous system). At present, there are no elements supporting the superiority or inferiority of one path compared to another. The difficulty lies within a clear estimation of the contractility state of the ventricular cardiac muscle.

Technological developments in recent years provided a solution to this problem. The analysis of the pressure/volume curves generated by a ventricle allows an accurate quantification of the myocardial contractility. This requires the use of conductance catheters to accurately measure the ventricular volume and the ventricular pressure. The absolute ventricular contractility is then deduced with the help of a software.

The investigators intend to use this pressure-volume loops, obtained with conductance catheters, to compare the contractility of the right heart ventricle after antegrade vs retrograde cardioplegia.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Antegrade cardioplegia
  • Procedure: Retrograde cardioplegia
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study of Myocardial Contractility After Cardiac Surgery Under an Anterograde or Retrograde Cardioplegia
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Antegrade Cardioplegia

Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)

Procedure: Antegrade cardioplegia
Injection of the cardioplegia in the coronary arteries

Experimental: Retrograde Cardioplegia

Coronary artery bypass grafting (CABG) surgery in patients with a normal left ventricular ejection fraction (FEVG)

Procedure: Retrograde cardioplegia
Injection of the cardioplegia in the venous system

Outcome Measures

Primary Outcome Measures

  1. Contractility index of the right ventricle [Baseline]

    Cardiac surgery is performed according to the standard of care. The intraventricular pressure and the ventricular volume, measured with a conductance catheter, are combined within a software to compute the contractility index of the right ventricle. The baseline measure will be performed before the instauration of the extracorporeal blood circulation, during the cardiac surgery.

  2. Contractility index of the right ventricle [immediately after discontinuation of the extracorporeal blood circulation (end of cardiac surgery according to standard of care - up to 4h)]

    Cardiac surgery is performed according to the standard of care. The intraventricular pressure and the ventricular volume, measured with a conductance catheter, are combined within a software to compute the contractility index of the right ventricle. This will be measured at the end of the cardiac surgery, immediately after discontinuation of the extracorporeal circulation, with absence of inotropic support.

  3. Contractility index of the right ventricle [10 minutes after discontinuation of the extracorporeal blood circulation]

    Cardiac surgery is performed according to the standard of care. The intraventricular pressure and the ventricular volume, measured with a conductance catheter, are combined within a software to compute the contractility index of the right ventricle. This will be measured at the end of the cardiac surgery, 10 minutes after discontinuation of the extracorporeal circulation, with absence of inotropic support.

  4. Contractility index of the right ventricle [20 minutes after discontinuation of the extracorporeal blood circulation]

    Cardiac surgery is performed according to the standard of care. The intraventricular pressure and the ventricular volume, measured with a conductance catheter, are combined within a software to compute the contractility index of the right ventricle. This will be measured at the end of the cardiac surgery, 20 minutes after discontinuation of the extracorporeal circulation, with absence of inotropic support.

Secondary Outcome Measures

  1. Troponin post operative level [6h post surgery]

    The investigators would like to measure post operative troponin levels as a biological marker of myocardial protection

  2. Troponin post operative level [12h post surgery]

    The investigators would like to measure post operative troponin as a biological marker of myocardial protection.

  3. Troponin post operative level [24h post surgery]

    The investigators would like to measure post operative troponin as a biological marker of myocardial protection.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Need for myocardial revascularisation

  • Normal FEVG ( > 50%)

Exclusion Criteria:
  • Valvulopathy

  • Associated procedures

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Brugmann Brussels Belgium 1020

Sponsors and Collaborators

  • Brugmann University Hospital

Investigators

  • Principal Investigator: Pierre Wauthy, MD, Pr, CHU Brugmann
  • Principal Investigator: Alessandro Falchetti, MD, CHU Brugmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pierre Wauthy, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier:
NCT02816385
Other Study ID Numbers:
  • CHUB-Retroplegie
First Posted:
Jun 28, 2016
Last Update Posted:
Nov 22, 2017
Last Verified:
Nov 1, 2017
Keywords provided by Pierre Wauthy, Head of clinic, Brugmann University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2017