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 |
| Secondary identifying numbers | CH0401 |
- 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
| 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 | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Insulin |
| Primary outcome measure | Cytokine levels |
| Secondary outcome measures | Complement concentration |
| Overall study start date | 01/09/2003 |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Radboud University Nijmegen Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Geert Groteplein 10
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 3617273 |
|---|---|
| H.vanderHoeven@ic.umcn.nl | |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Hospital/treatment centre
The Department of Intensive Care, Radboud University Nijmegen Medical Centre
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 | 01/09/2005 | Yes | No |
