The impact of hypocaloric diet with intensive insulin therapy on mortality and morbidity in adult critically ill patients

ISRCTN	ISRCTN96294863
DOI	https://doi.org/10.1186/ISRCTN96294863
Protocol serial number	RC-2005.30
Sponsor	King Abdulaziz City for Science and Technology (KACST) (Saudi Arabia)
Funder	King Abdulaziz City for Science and Technology (KACST) (Saudi Arabia)

Submission date: 22/07/2007
Registration date: 31/07/2007
Last edited: 14/04/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

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

Intensive Care Department
King Abdulaziz Medical City (KAMC) 1425
Riyadh
11426
Saudi Arabia

Phone	+9661 252 0088 Ext. 18855, 18877
Email	Yaseenarabi@yahoo.com

Study information

Primary study design	Interventional
Study design	Randomized controlled trial with concealed randomization using sealed envelops.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Hypocaloric diet with or without intensive insulin therapy is associated with better outcomes.
Ethics approval(s)	Approved by the Ethical Committee of King Fahad National Guard Hospital (ref: RC- 2005.30)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	insulin
Primary outcome measure(s)	ICU, 28 day and Hospital mortality.
Key secondary outcome measure(s)	1. ICU length of stay 2. Duration of mechanical ventilation 3. Incidence of nosocomial infections
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	240
Key inclusion criteria	1. Patients receiving nasogastric tube feeding 2. Aged >18 years 3. Staying >48 hours in Intensive Care Unit (ICU)
Key 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
Date of first enrolment	27/02/2006
Date of final enrolment	01/05/2008

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

Intensive Care Department

Riyadh
11426
Saudi Arabia

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2011		Yes	No