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

Mitral Valve Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818113
• Other study ID #: 2019-00070; ch18Grapow4
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Mitral Valve Reconstruction

Intervention

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

Locations

Country	Name	City	State
Switzerland	Klinik für Herzchirurgie, Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high specific troponin T (hs-TrT) (µg/l)	cardial biomarker for myocardial damage	perioperative during minimal invasive surgery
Primary	Creatin-Phosphokinase (CK) (U/l)	cardial biomarker for myocardial damage	perioperative during minimal invasive surgery
Primary	Creatinkinase Muscle- Brain (CK-MB) (U/l)	cardial biomarker for myocardial damage	perioperative during minimal invasive surgery
Secondary	mortality rate	number of deaths	from minimal invasive surgery until 30 days post surgery
Secondary	length of stay in intensive care unit (days)	length of stay in intensive care unit (number of days)	from minimal invasive surgery until 30 days post surgery