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Adenosine Cardioplegia; Improved Cardioprotection?

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01123525
Enrollment
60
Registered
2010-05-14
Start date
2010-04-30
Completion date
2011-09-30
Last updated
2011-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris

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.

Interventions

DRUGAdenosine

1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution

Sponsors

University Hospital of North Norway
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Release of cardiac enzymes (TnT and CKMB)First 48 hour postoperativelyRepeatedly measured postoperatively.

Secondary

MeasureTime frameDescription
PiCCOFirst 24 hours postoperativelyMeasurement of cardiac function and hemodynamics the first 24 hours postoperatively
Endothelial injuryPeroperatively (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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026