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 |
| Secondary identifying numbers | N0236173812 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | Nosocomial infection. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2002 |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 subjects and 100 controls, total 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
- England
- United Kingdom
Study participating centre
Anaesthetics Department
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
St George's Healthcare NHS Trust (UK), NHS R&D Support Funding
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 on nosocomial pneumonia and the presence of glucose in endotracheal secretion | 01/09/2005 | Yes | No |
