Contact information
Type
Scientific
Primary contact
Dr Yaseen Arabi
ORCID ID
Contact details
King Fahad National Guard Hospital
PO Box 22490
ICU 1425
Riyadh
11426
Saudi Arabia
+966 (0)1 252 0088 Ext 2498
yaseenarabi@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2002.11
Study information
Scientific title
The role of intensive insulin therapy in critically ill medical and surgical patients
Acronym
Insulin in ICU patients
Study hypothesis
Tight blood glucose control reduces mortality in critically ill patients.
Ethics approval
Received from local medical ethics committee, 12/03/2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/01/2004
Overall trial end date
30/11/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
522
Participant 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
Recruitment start date
01/01/2004
Recruitment end date
30/11/2005
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
King Fahad National Guard Hospital
Riyadh
11426
Saudi Arabia
Sponsor information
Organisation
King Fahad National Guard Hospital (Saudi Arabia)
Sponsor details
PO Box 22490
ICU 1425
Riyadh
11426
Saudi Arabia
+966 (0)1 252 0088 Ext 2498
icu1@ngha.med.sa
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
King Fahad National Guard Hospital (Saudi Arabia) - ICU Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18936702
2018 nested cohort study results in: http://www.ncbi.nlm.nih.gov/pubmed/29769112
Publication citations
-
Results
Arabi YM, Dabbagh OC, Tamim HM, Al-Shimemeri AA, Memish ZA, Haddad SH, Syed SJ, Giridhar HR, Rishu AH, Al-Daker MO, Kahoul SH, Britts RJ, Sakkijha MH, Intensive versus conventional insulin therapy: a randomized controlled trial in medical and surgical critically ill patients., Crit. Care Med., 2008, 36, 12, 3190-3197, doi: 10.1097/CCM.0b013e31818f21aa.