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| [ ...Back to search results ] | [ Print-friendly version ] |
| The role of intensive insulin therapy in critically ill medical and surgical patients |
| ISRCTN | ISRCTN07413772 |
| ClinicalTrials.gov identifier | |
| Public title | The role of intensive insulin therapy in critically ill medical and surgical patients |
| Scientific title | |
| Acronym | Insulin in ICU patients |
| Serial number at source | 2002.11 |
| Study hypothesis | Tight blood glucose control reduces mortality in critically ill patients. |
| Lay summary | |
| Ethics approval | Received from local medical ethics committee on the 12th March 2003 |
| Study design | Randomised controlled trial |
| Countries of recruitment | Saudi Arabia |
| Disease/condition/study domain | Critically ill medical and surgical patients |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/01/2004 |
| Anticipated end date | 30/11/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 522 |
| Interventions | 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. |
| Primary outcome measure(s) | All cause mortality in the ICU |
| Secondary outcome measure(s) |
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 |
| Sources of funding | King Fahad National Guard Hospital (Saudi Arabia) - ICU Research Fund |
| Trial website | |
| Publications | 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18936702 |
| Contact name | Dr Yaseen Arabi |
| Address |
King Fahad National Guard Hospital
PO Box 22490 ICU 1425 |
| City/town | Riyadh |
| Zip/Postcode | 11426 |
| Country | Saudi Arabia |
| Tel | +966 1 252 0088 Ext 2498 |
| Fax | +966 1 252 0088 Ext 2187 |
| yaseenarabi@yahoo.com | |
| Sponsor | King Fahad National Guard Hospital (Saudi Arabia) |
| Address |
PO Box 22490
ICU 1425 |
| City/town | Riyadh |
| Zip/Postcode | 11426 |
| Country | Saudi Arabia |
| Tel | +966 1 252 0088 Ext 2498 |
| Fax | +966 1 252 0088 Ext 2187 |
| icu1@ngha.med.sa | |
| Date applied | 03/07/2005 |
| Last edited | 03/12/2008 |
| Date ISRCTN assigned | 13/07/2005 |
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