The role of intensive insulin therapy in critically ill medical and surgical patients

ISRCTN	ISRCTN07413772
DOI	https://doi.org/10.1186/ISRCTN07413772
Protocol serial number	2002.11
Sponsor	King Fahad National Guard Hospital (Saudi Arabia)
Funder	King Fahad National Guard Hospital (Saudi Arabia) - ICU Research Fund

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Yaseen Arabi
Scientific

King Fahad National Guard Hospital
PO Box 22490
ICU 1425
Riyadh
11426
Saudi Arabia

Phone	+966 (0)1 252 0088 Ext 2498
Email	yaseenarabi@yahoo.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Insulin
Primary outcome measure(s)	All cause mortality in the ICU
Key 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
Completion date	30/11/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

King Fahad National Guard Hospital

Riyadh
11426
Saudi Arabia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

18/05/2018: added pub.