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Adenosine Cardioplegia; Improved Cardioprotection?

NCT ID: NCT01123525

Last Updated: 2011-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Angina Pectoris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Adenosine cardioplegia

Adenosine cardioplegia

Group Type EXPERIMENTAL

Adenosine

Intervention Type DRUG

1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution

Control

Standard hyperkalemic cardioplegia

Group Type ACTIVE_COMPARATOR

Adenosine

Intervention Type DRUG

1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution

Interventions

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Adenosine

1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of North Norway

Troomsø, , Norway

Site Status

Countries

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Norway

References

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Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.

Reference Type DERIVED
PMID: 22964356 (View on PubMed)

Other Identifiers

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2008-004274-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AdCard 2010

Identifier Type: -

Identifier Source: org_study_id