The role of intensive insulin therapy in critically ill medical and surgical patients
| ISRCTN | ISRCTN07413772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07413772 |
| Secondary identifying numbers | 2002.11 |
- Submission date
- 03/07/2005
- Registration date
- 13/07/2005
- Last edited
- 18/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Yaseen Arabi
Scientific
Scientific
King Fahad National Guard Hospital
PO Box 22490
ICU 1425
Riyadh
11426
Saudi Arabia
| Phone | +966 (0)1 252 0088 Ext 2498 |
|---|---|
| yaseenarabi@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The role of intensive insulin therapy in critically ill medical and surgical patients |
| Study acronym | Insulin in ICU patients |
| Study objectives | Tight blood glucose control reduces mortality in critically ill patients. |
| Ethics approval(s) | Received from local medical ethics committee, 12/03/2003 |
| Health condition(s) or problem(s) studied | Critically ill medical and surgical patients |
| Intervention | This is a randomised controlled trial. Patients will be randomly assigned to receive intensive insulin therapy (maintenance of blood glucose at a level between 4.4 - 6.1 mM/l or 80 - 110 mg/dl) or conventional treatment (infusion of insulin only if the blood glucose level exceeded 11.1 mM/l or 200 mg/dl) and maintenance of glucose at a level between 10 - 11.1 mM/l or 180 - 200 mg/dl) throughout their stay in ICU. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Insulin |
| Primary outcome measure | All cause mortality in the ICU |
| Secondary outcome measures | 1. Hospital outcome 2. Cause of death 3. ICU and hospital LOS 4. Mechanical ventilation duration 5. The need for renal replacement therapy 6. Transfusion requirements 7. ICU acquired infections 8. Causes of death |
| Overall study start date | 01/01/2004 |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 522 |
| Key inclusion criteria | 1. Adults (greater than 18 years old) able to give consent (directly or via proxy) 2. Random admission blood glucose level greater than 6.1 mM/l (greater than 110 mg/dl) |
| Key exclusion criteria | 1. Type I diabetes 2. Patients admitted with diabetic ketoacidosis 3. Patients with terminal illness (survival judged by the treating physician less than four weeks) 4. Patients with do not resuscitate (DNR) orders 5. Pregnancy 6. Patients with expected intensive care unit (ICU) length of stay (LOS) of less than 24 hours 7. History of hypoglycaemia during the same hospitalisation 8. Seizure disorder (known active in the last 6 months) 9. Post-cardiac arrest patients 10. Readmission to ICU within the same hospitalisation 11. Brain death 12. Liver transplant 13. Enrolled in another competing study 14. Refused consent 15. No consent within 24 hours of meeting inclusion criteria 16. Other reasons |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 30/11/2005 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
King Fahad National Guard Hospital
Riyadh
11426
Saudi Arabia
11426
Saudi Arabia
Sponsor information
King Fahad National Guard Hospital (Saudi Arabia)
Hospital/treatment centre
Hospital/treatment centre
PO Box 22490
ICU 1425
Riyadh
11426
Saudi Arabia
| Phone | +966 (0)1 252 0088 Ext 2498 |
|---|---|
| icu1@ngha.med.sa | |
"ROR" |
https://ror.org/009djsq06 |
Funders
Funder type
Hospital/treatment centre
King Fahad National Guard Hospital (Saudi Arabia) - ICU Research Fund
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 | 01/12/2008 | Yes | No | |
| Results article | nested cohort study results | 16/05/2018 | Yes | No |
Editorial Notes
18/05/2018: added pub.
