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The role of intensive insulin therapy in critically ill medical and surgical patients
ISRCTN ISRCTN07413772
DOI 10.1186/ISRCTN07413772
ClinicalTrials.gov identifier
EudraCT number
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
  Email 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
  Email icu1@ngha.med.sa
Date applied 03/07/2005
Last edited 03/12/2008
Date ISRCTN assigned 13/07/2005
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