Does nicorandil instead of supranormal potassium safely provide cardioplegia?

ISRCTN ISRCTN66723294
DOI https://doi.org/10.1186/ISRCTN66723294
Secondary identifying numbers N/A
Submission date
25/01/2006
Registration date
25/09/2006
Last edited
07/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Dag Sorlie
Scientific

Breivika
Tromsoe
9038
Norway

Phone +47 7762 6000
Email dag.sorlie@unn.no

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleDoes nicorandil instead of supranormal potassium safely provide cardioplegia?
Study objectivesNicorandil instead of supranormal potassium in cardioplegia is feasible, providing cardiac arrest and protection.
Ethics approval(s)Helse Nord research fund.
Health condition(s) or problem(s) studiedAngina pectoris
InterventionTwo groups of cardioplegia randomised to receive either:

1. Standard St. Thomas Hospital Solution (high [16 mM] potassium cardioplegia)
2. Nicorandil
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Nicorandil
Primary outcome measure1. Creatine Kinase Myocardial Band (CKMB)
2. Troponin
3. Cardiac Index (CI)
4. Saphenous Vein (SV)
5. Systemic Vascular Resistance (SVR)
6. Heart rate (HR)
7. Time to arrest
Secondary outcome measuresQuality of life
Overall study start date24/01/2005
Completion date26/09/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Total final enrolment50
Key inclusion criteria1. Aged 40 to 75 years
2. Elective to Coronary Artery Bypass Graft (CABG)
3. Ejection Fraction (EF) more than 40%
Key exclusion criteria1. Concomitant procedures
2. Emergency procedures
3. Glibenclamid medication
4. Pregnancy
Date of first enrolment24/01/2005
Date of final enrolment26/09/2005

Locations

Countries of recruitment

  • Norway

Study participating centre

Breivika
Tromsoe
9038
Norway

Sponsor information

University Hospital of North Norway (Norway)
University/education

Breivika
Tromsoe
9038
Norway

Phone +47 7762 6000
Email dag.sorlie@unn.no
Website http://www.unn.no/
ROR logo "ROR" https://ror.org/030v5kp38

Funders

Funder type

Government

Local Health Authorities

No information available

University Hospital of North Norway

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/07/2006 07/01/2021 Yes No

Editorial Notes

07/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.