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

Completed

• Conditions: Mitral Valve Reconstruction
• Interventions: Other: cardioplegia with St. Thomas cardioplegic solution; Other: cardioplegia with HTK-Bretschneider cardioplegic solution

• Registration Number: NCT03818113
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-28
• Study Start: 2019-04-01
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Creatin-Phosphokinase (CK) (U/l)	perioperative during minimal invasive surgery	cardial biomarker for myocardial damage
high specific troponin T (hs-TrT) (μg/l)	perioperative during minimal invasive surgery	cardial biomarker for myocardial damage
Creatinkinase Muscle- Brain (CK-MB) (U/l)	perioperative during minimal invasive surgery	cardial biomarker for myocardial damage

Secondary Outcome Measures

Name	Time	Method
mortality rate	from minimal invasive surgery until 30 days post surgery	number of deaths
length of stay in intensive care unit (days)	from minimal invasive surgery until 30 days post surgery	length of stay in intensive care unit (number of days)

Trial Locations

Locations (1)

Klinik für Herzchirurgie, Universitätsspital Basel; 🇨🇭 Basel, Switzerland