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 |
| Secondary identifying numbers | RC-2005.30 |
- 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
Scientific
Intensive Care Department
King Abdulaziz Medical City (KAMC) 1425
Riyadh
11426
Saudi Arabia
| Phone | +9661 252 0088 Ext. 18855, 18877 |
|---|---|
| Yaseenarabi@yahoo.com |
Study information
| Study design | Randomized controlled trial with concealed randomization using sealed envelops. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | insulin |
| Primary outcome measure | 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 study start date | 27/02/2006 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
11426
Saudi Arabia
Sponsor information
King Abdulaziz City for Science and Technology (KACST) (Saudi Arabia)
Government
Government
P.O. Box 6086
Riyadh 11442
11426
Saudi Arabia
| Phone | +9661 4833444 |
|---|---|
| icu1@ngha.med.sa | |
| Website | http://www.ngha.med.sa/en/m-cities/cr/dep/icu/index.htm |
"ROR" |
https://ror.org/05tdz6m39 |
Funders
Funder type
Government
King Abdulaziz City for Science and Technology (KACST) (Saudi Arabia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
