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
Scientific
Breivika
Tromsoe
9038
Norway
| Phone | +47 7762 6000 |
|---|---|
| dag.sorlie@unn.no |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nicorandil |
| Primary outcome measure | 1. 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 measures | Quality of life |
| Overall study start date | 24/01/2005 |
| Completion date | 26/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
University Hospital of North Norway (Norway)
University/education
University/education
Breivika
Tromsoe
9038
Norway
| Phone | +47 7762 6000 |
|---|---|
| dag.sorlie@unn.no | |
| Website | http://www.unn.no/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
