Adenosine Cardioplegia; Improved Cardioprotection?

Angina Pectoris Clinical Trial

Official title:

Adenosine Instead of Supranormal Potassium in Crystalloid Cardioplegia, a Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123525
• Other study ID #: AdCard 2010
• Secondary ID: 2008-004274-40
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 30, 2010
• Last updated: September 29, 2011
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

Drug:
• Adenosine
1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Troomsø

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Release of cardiac enzymes (TnT and CKMB)	Repeatedly measured postoperatively.	First 48 hour postoperatively	No
Secondary	PiCCO	Measurement of cardiac function and hemodynamics the first 24 hours postoperatively	First 24 hours postoperatively	No
Secondary	Endothelial injury	Measurements of markers of endothelial injury/dysfunction peroperatively. Blood will be sampled immediately before cross-clamping the aorta and after 5 minutes of reperfusion.	Peroperatively (before crossclamping aorta and after 5 minutes of reperfusion)	No