Adenosine Cardioplegia; Improved Cardioprotection?

Phase 1

Completed

• Conditions: Angina Pectoris
• Interventions: Drug: Adenosine

• Registration Number: NCT01123525
• Lead Sponsor: University Hospital of North Norway

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-14
• Primary Completion: 2011-04
• Status Verified: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-29
• Last Update Posted: 2011-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adenosine cardioplegia	Adenosine	Adenosine cardioplegia
Control	Adenosine	Standard hyperkalemic cardioplegia

Primary Outcome Measures

Name	Time	Method
Release of cardiac enzymes (TnT and CKMB)	First 48 hour postoperatively	Repeatedly measured postoperatively.

Secondary Outcome Measures

Name	Time	Method
PiCCO	First 24 hours postoperatively	Measurement of cardiac function and hemodynamics the first 24 hours postoperatively
Endothelial injury	Peroperatively (before crossclamping aorta and after 5 minutes of reperfusion)	Measurements of markers of endothelial injury/dysfunction peroperatively. Blood will be sampled immediately before cross-clamping the aorta and after 5 minutes of reperfusion.

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Troomsø, Norway