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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03818113

Enrollment

200

Registered

2019-01-28

Start date

2019-04-01

Completion date

2019-08-30

Last updated

2019-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Reconstruction

Keywords

mitral valve insufficiency, cardioplegia, cardioplegia Solution, HTK-Bretschneider (Custidiol®) solution, St. Thomas solution, cardiac biomarker

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.

Interventions

OTHERcardioplegia with HTK-Bretschneider cardioplegic solution

cardioplegia with HTK-Bretschneider cardioplegic solution

OTHERcardioplegia with St. Thomas cardioplegic solution

cardioplegia with St. Thomas cardioplegic solution

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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).

Design outcomes

Primary

Measure	Time frame	Description
high specific troponin T (hs-TrT) (μg/l)	perioperative during minimal invasive surgery	cardial biomarker for myocardial damage
Creatin-Phosphokinase (CK) (U/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

Measure	Time frame	Description
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)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026