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

NCT02816385 | Completed

• 1 other identifier: CHUB-Retroplegie
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Arrest

Keywords

PV-loops (pressure-volume loops); Myocardial contractility; Cardioplegia; Induced

Outcome Measures

Primary Outcomes (4)

• Contractility index of the right ventricle

  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.

  Baseline

• Contractility index of the right ventricle

  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.

  immediately after discontinuation of the extracorporeal blood circulation (end of cardiac surgery according to standard of care - up to 4h)

• Contractility index of the right ventricle

  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.

  10 minutes after discontinuation of the extracorporeal blood circulation

• Contractility index of the right ventricle

  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.

  20 minutes after discontinuation of the extracorporeal blood circulation

Secondary Outcomes (3)

• Troponin post operative level

  6h post surgery

• Troponin post operative level

  12h post surgery

• Troponin post operative level

  24h post surgery

Study Arms (2)

Antegrade Cardioplegia

ACTIVE COMPARATOR

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

Procedure: Antegrade cardioplegia

Retrograde Cardioplegia

EXPERIMENTAL

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

Procedure: Retrograde cardioplegia

Interventions

Antegrade cardioplegia PROCEDURE

Injection of the cardioplegia in the coronary arteries

Antegrade Cardioplegia

Retrograde cardioplegia PROCEDURE

Injection of the cardioplegia in the venous system

Retrograde Cardioplegia

Eligibility Criteria

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

You may qualify if:

• Need for myocardial revascularisation
• Normal FEVG ( \> 50%)

You may not qualify if:

• Valvulopathy
• Associated procedures

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Pierre Wauthy, MD, Pr

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

• Alessandro Falchetti, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: June 28, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

BE (1)