Intensive insulin therapy does not alter the inflammatory response in patients undergoing coronary artery bypass graft (CABG): a randomized controlled trial
| ISRCTN | ISRCTN95608630 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95608630 |
| Protocol serial number | CH0401 |
| Sponsor | Radboud University Nijmegen Medical Centre (The Netherlands) |
| Funder | The Department of Intensive Care, Radboud University Nijmegen Medical Centre |
- Submission date
- 24/08/2005
- Registration date
- 26/08/2005
- Last edited
- 29/11/2007
- 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
Dr Cornelia Hoedemaekers
Scientific
Scientific
Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands
| C.Hoedemaekers@ic.umcn.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | CH0401 |
| Study objectives | Strict glucose control in critically ill patients alters the cytokine balance towards a more pro-inflammatory state. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Coronary artery bypass graft |
| Intervention | Strict glucose control (blood glucose between 80-110 mg/dl) versus placebo (blood glucose >200 mg/dl). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Insulin |
| Primary outcome measure(s) |
Cytokine levels |
| Key secondary outcome measure(s) |
Complement concentration |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Adults, after uncomplicated CABG 2. Non-diabetics |
| Key exclusion criteria | 1. Diabetes 2. Renal failure 3. Use of anti-inflammatory drugs 4. Recent myocardial ischemia |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/11/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
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 | 01/09/2005 | Yes | No |
