Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy

University Hospital Basel

Status: Completed

Conditions: Mitral Valve Reconstruction

Treatments: Other: cardioplegia with St. Thomas cardioplegic solution; Other: cardioplegia with HTK-Bretschneider cardioplegic solution

Study type: Observational

Funder types: Other

Identifiers

NCT03818113

2019-00070 ch18Grapow4;

Details and patient eligibility

About

Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

Exclusion criteria

• Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

Trial design

200 participants in 2 patient groups

HTK-Bretschneider cardioplegic solution

Description:

Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with HTK-Bretschneider cardioplegic solution

Treatment:

Other: cardioplegia with HTK-Bretschneider cardioplegic solution

St. Thomas cardioplegic solution

Description:

Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with St. Thomas cardioplegic solution

Treatment:

Other: cardioplegia with St. Thomas cardioplegic solution