Does nicorandil instead of supranormal potassium safely provide cardioplegia?
| ISRCTN | ISRCTN66723294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66723294 |
| Protocol serial number | N/A |
| Sponsor | University Hospital of North Norway (Norway) |
| Funders | Local Health Authorities, University Hospital of North Norway |
- 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
Scientific
Breivika
Tromsoe
9038
Norway
| Phone | +47 7762 6000 |
|---|---|
| dag.sorlie@unn.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Does nicorandil instead of supranormal potassium safely provide cardioplegia? |
| Study objectives | Nicorandil 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) studied | Angina pectoris |
| Intervention | Two groups of cardioplegia randomised to receive either: 1. Standard St. Thomas Hospital Solution (high [16 mM] potassium cardioplegia) 2. Nicorandil |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nicorandil |
| Primary outcome measure(s) |
1. Creatine Kinase Myocardial Band (CKMB) |
| Key secondary outcome measure(s) |
Quality of life |
| Completion date | 26/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Aged 40 to 75 years 2. Elective to Coronary Artery Bypass Graft (CABG) 3. Ejection Fraction (EF) more than 40% |
| Key exclusion criteria | 1. Concomitant procedures 2. Emergency procedures 3. Glibenclamid medication 4. Pregnancy |
| Date of first enrolment | 24/01/2005 |
| Date of final enrolment | 26/09/2005 |
Locations
Countries of recruitment
- Norway
Study participating centre
Breivika
Tromsoe
9038
Norway
9038
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
