Adenosine Cardioplegia; Improved Cardioprotection?

September 29, 2011 updated by: University Hospital of North Norway

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Troomsø, Norway, 9038
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Release of cardiac enzymes (TnT and CKMB)
Time Frame: First 48 hour postoperatively
Repeatedly measured postoperatively.
First 48 hour postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PiCCO
Time Frame: First 24 hours postoperatively
Measurement of cardiac function and hemodynamics the first 24 hours postoperatively
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.
Peroperatively (before crossclamping aorta and after 5 minutes of reperfusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

April 30, 2010

First Submitted That Met QC Criteria

May 12, 2010

First Posted (ESTIMATE)

May 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 30, 2011

Last Update Submitted That Met QC Criteria

September 29, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AdCard 2010
  • 2008-004274-40 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Angina Pectoris

Clinical Trials on Adenosine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe