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Clinical Trials/NCT03818113
NCT03818113
Completed
Not Applicable

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

University Hospital, Basel, Switzerland1 site in 1 country200 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Valve Reconstruction
Sponsor
University Hospital, Basel, Switzerland
Enrollment
200
Locations
1
Primary Endpoint
Creatin-Phosphokinase (CK) (U/l)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
August 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Creatin-Phosphokinase (CK) (U/l)

Time Frame: perioperative during minimal invasive surgery

cardial biomarker for myocardial damage

high specific troponin T (hs-TrT) (μg/l)

Time Frame: perioperative during minimal invasive surgery

cardial biomarker for myocardial damage

Creatinkinase Muscle- Brain (CK-MB) (U/l)

Time Frame: perioperative during minimal invasive surgery

cardial biomarker for myocardial damage

Secondary Outcomes

  • mortality rate(from minimal invasive surgery until 30 days post surgery)
  • length of stay in intensive care unit (days)(from minimal invasive surgery until 30 days post surgery)

Study Sites (1)

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