Efficacy of metoprolol CR/XL on diabetic postoperative mortality and cardiovascular morbidity: a randomised, double blind, placebo-controlled, multicentre trial
| ISRCTN | ISRCTN58485613 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58485613 |
| Protocol serial number | Not Applicable |
| Sponsor | Copenhagen Trial Unit (Denmark) |
| Funders | The Danish Heart Foundation (Denmark) (ref: 01-2-5-51A-22931), The Danish Diabetes Foundation (Denmark) (ref: C.1), The Copenhagen Hospital Corporation's Research Council (Denmark) (ref: 109/01), Programme for Strengthening Regional Collaboration within Medical Health Research (Denmark) (ref: 301-070-5199), AstraZeneca (Denmark) (ref: AD-MET-0003) |
- Submission date
- 27/02/2002
- Registration date
- 27/02/2002
- Last edited
- 06/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anne Benedicte Juul
Scientific
Scientific
Copenhagen Trial Unit
Centre for Clinical Intervention Research
H:S Rigshospitalet
Dept 7102
Copenhagen Ø
DK-2100
Denmark
| Phone | +45 3545 7156 or +45 3526 7235 |
|---|---|
| Anne.j@ctu.rh.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | DIPOM |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diabetes mellitus and major surgery |
| Intervention | Diabetic patients undergoing major noncardiac surgery are randomised to 7 days of perioperative beta blocking (Metoprolol CR/XL [SeloZok®] 100 mg daily) versus placebo treatment. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metoprolol CR/XL |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Key inclusion criteria | Patients 40 years of age with diabetes undergoing noncardiac major (lasting more than 1 hour) surgery |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2000 |
| Date of final enrolment | 01/07/2002 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Copenhagen Trial Unit
Copenhagen Ø
DK-2100
Denmark
DK-2100
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 24/06/2006 | Yes | No |
