A randomised controlled trial investigating the effect of strict glycaemic control on the incident of nosocomial infection in critically ill patients
| ISRCTN | ISRCTN24412536 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24412536 |
| Protocol serial number | N0236173812 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | St George's Healthcare NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 10/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Barbara Philips
Scientific
Scientific
Anaesthetics Department
Jenner Wing
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
| Phone | +44 (0)20 8725 5071 |
|---|---|
| bphilips@sghms.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. To investigate the association between strict glycaemic control and the subsequent development of nosocomial infection. 2. To determine the relationship between nosocomial pneumonia and the presence of glucose in endotracheal secretion. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Infections and Infestations: Nosocomial infections |
| Intervention | All ventilated patients will be randomised to 2 groups: Group 1 - the treatment group: a continuous infusion of insulin will be started once blood glucose levels exceed 6.1 mmol/l and adjusted accordingly to maintain blood sugar levels between 4.4 and 6.1 mmol/l Group 2 - the control group: insulin will be adjusted to maintain blood glucose levels <= 10 mmol/l |
| Intervention type | Other |
| Primary outcome measure(s) | Nosocomial infection. |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 200 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Anaesthetics Department
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
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 on nosocomial pneumonia and the presence of glucose in endotracheal secretion | 01/09/2005 | Yes | No |
