Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/07/2007
Date assigned
31/07/2007
Last edited
14/04/2011
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

Intensive Care Department
King Abdulaziz Medical City (KAMC) 1425
Riyadh
11426
Saudi Arabia
+9661 252 0088 Ext. 18855, 18877
Yaseenarabi@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RC-2005.30

Study information

Scientific title

Acronym

Study hypothesis

Hypocaloric diet with or without intensive insulin therapy is associated with better outcomes.

Ethics approval

Approved by the Ethical Committee of King Fahad National Guard Hospital (ref: RC- 2005.30)

Study design

Randomized controlled trial with concealed randomization using sealed envelops.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Intensive care, critically ill patients

Intervention

All patients admitted to ICU are screened for eligibility. Once patient is eligible for study, informed consent is obtained from the next of kin. The patient is then randomized to one of the following arms:
1. Eu-caloric diet (target 90-100% of caloric requirement estimated by Harris-Benedict equation) and conventional insulin (insulin administered when the blood glucose level exceeds 11.1 mmol / liter with the use of insulin infusion in order to keep the blood glucose between 10.0-11.1mmol / liter)
2. Eu-caloric diet and intensive insulin (insulin administered when the blood glucose level exceeded 6.1mmol / liter with the use of insulin infusion to keep blood glucose between 4.4-6.1mmol / liter)
3. Hypo-caloric diet (target 60- 70% of caloric requirement estimated by Harris-Benedict equation) and conventional insulin
4. Hypo-caloric diet and intensive insulin

Intervention type

Drug

Phase

Not Specified

Drug names

insulin

Primary outcome measures

ICU, 28 day and Hospital mortality.

Secondary outcome measures

1. ICU length of stay
2. Duration of mechanical ventilation
3. Incidence of nosocomial infections

Overall trial start date

27/02/2006

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients receiving nasogastric tube feeding
2. Aged >18 years
3. Staying >48 hours in Intensive Care Unit (ICU)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Refused consent
2. Terminal illness
3. DNR (Do Not Recussitate; no code, no escalation) in first 48 hours of admission
4. Enteral feeding cannot be started within 48 hours
5. Total Parentral Nutrition (TPN)
6. Oral feeding
7. Liver transplant
8. Seizures within last 6 months
9. Expected to stay less than 48 hours
10. Age less than 17 years
11. Readmission
12. Brain dead within 48 hours
13. Pregnancy
14. Post cardiac arrest
15. Enrolled in another study
16. Hypoglycemic coma
17. Blood glucose less than 6.1mmol in first 48 hours
18. Type 1 diabetes

Recruitment start date

27/02/2006

Recruitment end date

01/05/2008

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

Intensive Care Department
Riyadh
11426
Saudi Arabia

Sponsor information

Organisation

King Abdulaziz City for Science and Technology (KACST) (Saudi Arabia)

Sponsor details

P.O. Box 6086
Riyadh 11442
11426
Saudi Arabia
+9661 4833444
icu1@ngha.med.sa

Sponsor type

Government

Website

http://www.ngha.med.sa/en/m-cities/cr/dep/icu/index.htm

Funders

Funder type

Government

Funder name

King Abdulaziz City for Science and Technology (KACST) (Saudi Arabia)

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21270385

Publication citations

  1. Results

    Arabi YM, Tamim HM, Dhar GS, Al-Dawood A, Al-Sultan M, Sakkijha MH, Kahoul SH, Brits R, Permissive underfeeding and intensive insulin therapy in critically ill patients: a randomized controlled trial., Am. J. Clin. Nutr., 2011, 93, 3, 569-577, doi: 10.3945/ajcn.110.005074.

Additional files

Editorial Notes