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

ISRCTN ISRCTN07413772
DOI https://doi.org/10.1186/ISRCTN07413772
Secondary identifying numbers 2002.11
Submission date
03/07/2005
Registration date
13/07/2005
Last edited
18/05/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe role of intensive insulin therapy in critically ill medical and surgical patients
Study acronymInsulin in ICU patients
Study objectivesTight 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) studiedCritically ill medical and surgical patients
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Insulin
Primary outcome measureAll cause mortality in the ICU
Secondary outcome measures1. 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 study start date01/01/2004
Completion date30/11/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants522
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2004
Date of final enrolment30/11/2005

Locations

Countries of recruitment

  • Saudi Arabia

Study participating centre

King Fahad National Guard Hospital
Riyadh
11426
Saudi Arabia

Sponsor information

King Fahad National Guard Hospital (Saudi Arabia)
Hospital/treatment centre

PO Box 22490
ICU 1425
Riyadh
11426
Saudi Arabia

Phone +966 (0)1 252 0088 Ext 2498
Email icu1@ngha.med.sa
ROR logo "ROR" https://ror.org/009djsq06

Funders

Funder type

Hospital/treatment centre

King Fahad National Guard Hospital (Saudi Arabia) - ICU Research Fund

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

18/05/2018: added pub.