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Adenosine Cardioplegia; Improved Cardioprotection?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01123525
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : September 30, 2011
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE April 30, 2010
First Posted Date  ICMJE May 14, 2010
Last Update Posted Date September 30, 2011
Study Start Date  ICMJE April 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2010)
Release of cardiac enzymes (TnT and CKMB) [ Time Frame: First 48 hour postoperatively ]
Repeatedly measured postoperatively.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01123525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2010)
  • PiCCO [ Time Frame: First 24 hours postoperatively ]
    Measurement of cardiac function and hemodynamics the first 24 hours postoperatively
  • Endothelial injury [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adenosine Cardioplegia; Improved Cardioprotection?
Official Title  ICMJE Adenosine Instead of Supranormal Potassium in Crystalloid Cardioplegia, a Randomized Clinical Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Angina Pectoris
Intervention  ICMJE Drug: Adenosine
1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution
Study Arms  ICMJE
  • Experimental: Adenosine cardioplegia
    Adenosine cardioplegia
    Intervention: Drug: Adenosine
  • Active Comparator: Control
    Standard hyperkalemic cardioplegia
    Intervention: Drug: Adenosine
Publications * Jakobsen Ø, Næsheim T, Aas KN, Sørlie 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 12, 2010)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01123525
Other Study ID Numbers  ICMJE AdCard 2010
2008-004274-40 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital of North Norway
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP