Adenosine Cardioplegia; Improved Cardioprotection?
Adenosine Instead of Supranormal Potassium in Crystalloid Cardioplegia, a Randomized Clinical Study
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 30, 2010
CompletedFirst Posted
Study publicly available on registry
May 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 30, 2011
September 1, 2011
1 year
April 30, 2010
September 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Release of cardiac enzymes (TnT and CKMB)
Repeatedly measured postoperatively.
First 48 hour postoperatively
Secondary Outcomes (2)
PiCCO
First 24 hours postoperatively
Endothelial injury
Peroperatively (before crossclamping aorta and after 5 minutes of reperfusion)
Study Arms (2)
Adenosine cardioplegia
EXPERIMENTALAdenosine cardioplegia
Control
ACTIVE COMPARATORStandard hyperkalemic cardioplegia
Interventions
1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution
Eligibility Criteria
You may qualify if:
- Elective patients
- Ejection fraction \> 40%
- Age 40-75
- No release og TnT or CKMB within last week before CABG
- Pure CABG
You may not qualify if:
- Age \>75 or \< 40
- EF \< 40%
- Emergency operations
- Unstable angina
- Release of TnT or CKMB within the week before operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of North Norway
Troomsø, 9038, Norway
Related Publications (1)
Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.
PMID: 22964356DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2010
First Posted
May 14, 2010
Study Start
April 1, 2010
Primary Completion
April 1, 2011
Study Completion
September 1, 2011
Last Updated
September 30, 2011
Record last verified: 2011-09