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Completed

NCT Number: NCT01123525

Adenosine Cardioplegia; Improved Cardioprotection?

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.

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Key information

Conditions

Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital of North Norway

Troomsø, 9038, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adenosine

Drug

1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution

Primary outcomes

  1. Release of cardiac enzymes (TnT and CKMB)

    Time frame: First 48 hour postoperatively

    Repeatedly measured postoperatively.

Secondary outcomes

  1. PiCCO

    Time frame: First 24 hours postoperatively

    Measurement of cardiac function and hemodynamics the first 24 hours postoperatively

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 14, 2010
Registry last updated
Sep 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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