Cardioplegic Protection of the Heart

Region Skane

Status and phase: Completed; Phase 4

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

Treatments: Drug: Modified Buckberg cardioplegic solution; Drug: Modified St Thomas´ cardioplegic solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07386990

2021-01728

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Buckberg cardioplegia

Experimental group

Treatment:

Drug: Modified Buckberg cardioplegic solution

St Thomas´ cardioplegia

Active Comparator group

Treatment:

Drug: Modified St Thomas´ cardioplegic solution