Condition category
Not Applicable
Date applied
03/07/2005
Date assigned
13/07/2005
Last edited
03/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 1 252 0088 Ext 2498
yaseenarabi@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2002.11

Study information

Scientific title

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 on the 12th March 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

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 Specified

Drug names

Insulin

Primary outcome measures

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

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 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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18936702

Publication citations

  1. 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.

Additional files

Editorial Notes