Adenosine Cardioplegia; Improved Cardioprotection?

University Hospital of North Norway

Status and phase: Completed; Phase 2; Phase 1

Conditions: Angina Pectoris

Treatments: Drug: Adenosine

Study type: Interventional

Funder types: Other

Identifiers

NCT01123525

2008-004274-40 (EudraCT Number)

AdCard 2010

Details and patient eligibility

About

60 elective patients for CABG will be included to receive either standard hyperkalemic cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective patients
• Ejection fraction > 40%
• Age 40-75
• No release og TnT or CKMB within last week before CABG
• Pure CABG

Exclusion criteria

• Age >75 or < 40
• EF < 40%
• Emergency operations
• Unstable angina
• Release of TnT or CKMB within the week before operation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Adenosine cardioplegia

Experimental group

Description:

Adenosine cardioplegia

Treatment:

Drug: Adenosine

Control

Active Comparator group

Description:

Standard hyperkalemic cardioplegia

Treatment:

Drug: Adenosine