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 |
| Secondary identifying numbers | Not Applicable |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DIPOM |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metoprolol CR/XL |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2000 |
| Overall study end date | 01/07/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | Patients 40 years of age with diabetes undergoing noncardiac major (lasting more than 1 hour) surgery |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/07/2000 |
| Recruitment end date | 01/07/2002 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Copenhagen Trial Unit
Copenhagen Ø
DK-2100
Denmark
DK-2100
Denmark
Sponsor information
Copenhagen Trial Unit (Denmark)
Research organisation
Research organisation
Centre for Clinical Intervention Research
H:S Rigshospitalet
Dept 7102
Copenhagen Ø
DK-2100
Denmark
"ROR" |
https://ror.org/05bpbnx46 |
|---|
Funders
Funder type
Charity
The Danish Heart Foundation (Denmark) (ref: 01-2-5-51A-22931)
No information available
The Danish Diabetes Foundation (Denmark) (ref: C.1)
No information available
The Copenhagen Hospital Corporation's Research Council (Denmark) (ref: 109/01)
No information available
Programme for Strengthening Regional Collaboration within Medical Health Research (Denmark) (ref: 301-070-5199)
No information available
AstraZeneca (Denmark) (ref: AD-MET-0003)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
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 | 24/06/2006 | Yes | No |
