Adenosine Cardioplegia; Improved Cardioprotection?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01123525
First received: April 30, 2010
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Angina Pectoris
Drug: Adenosine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adenosine Instead of Supranormal Potassium in Crystalloid Cardioplegia, a Randomized Clinical Study

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Release of cardiac enzymes (TnT and CKMB) [ Time Frame: First 48 hour postoperatively ] [ Designated as safety issue: No ]
    Repeatedly measured postoperatively.


Secondary Outcome Measures:
  • PiCCO [ Time Frame: First 24 hours postoperatively ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Measurements of markers of endothelial injury/dysfunction peroperatively. Blood will be sampled immediately before cross-clamping the aorta and after 5 minutes of reperfusion.


Estimated Enrollment: 60
Study Start Date: April 2010
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adenosine cardioplegia
Adenosine cardioplegia
Drug: Adenosine
1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution
Active Comparator: Control
Standard hyperkalemic cardioplegia
Drug: Adenosine
1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123525

Locations
Norway
University Hospital of North Norway
Troomsø, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
  More Information

No publications provided by University Hospital of North Norway

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01123525     History of Changes
Other Study ID Numbers: AdCard 2010, 2008-004274-40
Study First Received: April 30, 2010
Last Updated: September 29, 2011
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 16, 2014