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Completed

NCT Number: NCT07386990

Cardioplegic Protection of the Heart

This study seek to compare two different solutions used to protect the heart during cardiac surgery. 40 adult patients planned for coronary artery bypass surgery with cardiopulmonary bypass machine assistance will be included in the study. Blood samples from the first 48 hours after surgery will be analyzed together with physical data, x-ray-results, ecg and general outcome after surgery.

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Key information

Conditions

Coronary Artery Bypass Graft (CABG) Cardioplegia Cardiopulmonary Bypass Perioperative Myocardial Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiothoracic surgery department, Skåne university hospital, Lund

Lund, 22242, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for non urgent, single procedure coronary artery bypass grafting surgery at Skåne university hospital in Lund Sweden

Exclusion criteria

*Heart failure (=Left ventricular ejection fraction less than 40 %).

  • Moderate and severe aortic valve insufficiency.
  • Type 1 diabetes.
  • Renal insufficiency (=estimated glomerular filtration rate <60 mL/min/1,73m2)
  • Not communicating in Swedish language.
  • Previous cardiac surgery.

Treatment and study plan

Modified Buckberg cardioplegic solution

Drug

Study subjects randomized to this study group will receive Modified Buckberg cardioplegic solution during coronary artery bypass grafting operation.

Modified St Thomas´ cardioplegic solution

Drug

Study subjects randomized to this study group will receive Modified St Thomas hospital´s cardioplegic solution during coronary artery bypass grafting operation.

Primary outcomes

  1. CKMB

    Time frame: 48 hours after surgery (cross clamp release)

    Peak plasma levels of Creatin kinase muscle brain 0,18-300 µg/L

Secondary outcomes

  1. hs-cTnT

    Time frame: 48 hours after surgery (cross clamp release)

    peak level of plasma hig sensitive cardiac Troponin T after surgery 3 - 10 000 ng/L

  2. hs-cTnI

    Time frame: 48 hours after surgery (cross clamp release)

    peak plasma level of high sensitive cardiac Troponin I after surgery 2,50-25 000 ng/L

  3. Pacemaker

    Time frame: two hours after aortic cross clamp release

    Rate of required use of temporary pacemaker after aortic cross clamp release

  4. DC cardioversion

    Time frame: during the surgical procedure in the operating room

    Rate of required use of direct current cardioversion to treat arrythmia after aortic cross clamp release

  5. Cardiometabolic protein profile

    Time frame: 2 hours after surgery

    Levels of 92 cardiometabolic proteins analyzed with proximity extension assay technique before and two hours after surgery.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

The Type of Cardioplegia and Cardiometabolic Impact - a Prospective Randomized Trial in Patients Undergoing CABG

Important dates

Study start
2021
Primary completion
2021
Study completion
2025
First posted
Feb 4, 2026
Registry last updated
Feb 12, 2026

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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