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Completed

NCT Number: NCT03818113

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

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.

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Key information

Conditions

Mitral Valve Reconstruction Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Herzchirurgie, Universitätsspital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

cardioplegia with HTK-Bretschneider cardioplegic solution

Other

cardioplegia with HTK-Bretschneider cardioplegic solution

cardioplegia with St. Thomas cardioplegic solution

Other

cardioplegia with St. Thomas cardioplegic solution

Primary outcomes

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

    Time frame: perioperative during minimal invasive surgery

    cardial biomarker for myocardial damage

  2. Creatin-Phosphokinase (CK) (U/l)

    Time frame: perioperative during minimal invasive surgery

    cardial biomarker for myocardial damage

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

    Time frame: perioperative during minimal invasive surgery

    cardial biomarker for myocardial damage

Secondary outcomes

  1. mortality rate

    Time frame: from minimal invasive surgery until 30 days post surgery

    number of deaths

  2. length of stay in intensive care unit (days)

    Time frame: from minimal invasive surgery until 30 days post surgery

    length of stay in intensive care unit (number of days)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2019
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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