Permissive underfeeding versus target enteral feeding in adult critically ill patients
| ISRCTN | ISRCTN68144998 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68144998 |
| Protocol serial number | RC08/040 |
| Sponsor | King Abdullah International Medical Research Center (KAIMRC) (Saudi Arabia) |
| Funders | King Abdullah International Medical Research Center (KAIMRC) (Saudi Arabia), King Abdul Aziz Medical City (Saudi Arabia) |
- Submission date
- 12/05/2009
- Registration date
- 24/06/2009
- Last edited
- 15/04/2020
- 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 MD, FCCP, FCCM
Scientific
Scientific
Chairman, Intensive Care Department
Assistant Professor
College of Medicine
King Saud Bin Abdulaziz University for Health Sciences
King Abdulaziz Medical City
Riyadh
11426
Saudi Arabia
| Phone | +966 (0)1 252 0088 ext. 18855 |
|---|---|
| yaseenarabi@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The impact of permissive underfeeding versus target enteral feeding on mortality and morbidity in adult critically ill patients: a multicentre randomised controlled trial |
| Study objectives | 1. To assess the effect of permissive underfeeding versus target feeding intake on mortality and morbidity of critically ill patients 2. To assess the effect of low versus high caloric intake on the incidence of nosocomial infections Due to an error made at the time of registration, the overall trial end date was showing as 01/09/2009. As of 02/11/2010 this has now been amended and the correct end date of 01/09/2013 has been added to the overall trial end date field below. On 06/11/2014 the following changes were made to the trial record: 1. The target number of participants was changed from 862 to 892. 2. The overall trial end date was changed from 01/09/2013 to 30/12/2014. |
| Ethics approval(s) | Institutional Review Board of the National Guard Health Affairs, King Abdul Aziz Medical City, 08/04/2009, ref: IRBC/017/09 |
| Health condition(s) or problem(s) studied | Enteral feeding |
| Intervention | All patients admitted to ICU will be screened within first 48 hours for eligiliblity and all potential eligible candidates will be identified. Patients will be allocated to one of the two groups: 1. Permissive underfeeding group: intake targeting 40 - 60% of calculated caloric requirement 2. Target group: intake targeting 70 - 100% of calculated caloric requirement The allocated diet (permissive underfeeding versus target feeding) will be undertaken for a maximum of 14 days on study feeding protocol or at ICU discharge (whichever is earlier). Upon discharge from the ICU, feeding and glucose control will be at the discretion of ward clinicians. If oral feeding is started and tolerated for more than 24 hours, a Do-Not-Resuscitate order has been written (after enrolment) or brain death is confirmed (after enrolment) the study will be stopped in these participants. |
| Intervention type | Other |
| Primary outcome measure(s) |
90 day-all cause mortality: death before or at day 90 of enrolment |
| Key secondary outcome measure(s) |
1. ICU mortality: death in the ICU during the same ICU admission |
| Completion date | 30/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 892 |
| Key inclusion criteria | 1. Receiving enteral feeding 2. Aged greater than or equal to 18 years, either sex 3. Expected to stay 48 hours or more in the ICU |
| Key exclusion criteria | 1. Terminal illness 2. Do not resuscitate (DNR) order (no code, no escalation) in the first 48 hours 3. Enteral feeding cannot be started within 48 hours of admission 4. Total parenteral nutrition (TPN) 5. Oral feeding 6. Previously enrolled in this study within the same hospital admission 7. Brain death within 48 hours of admission 8. Pregnancy 9. Post-liver transplant 10. Post cardiac arrest 11. Burn patients 12. Prisoners 13. Elderly subjects aged greater than 80 years 14. Patients on more than one ionotropic support at maximum dose |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 30/12/2014 |
Locations
Countries of recruitment
- Bahrain
- Canada
- Germany
- Saudi Arabia
- United Arab Emirates
Study participating centre
King Saud Bin Abdulaziz University for Health Sciences
Riyadh
11426
Saudi Arabia
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 | 18/06/2015 | Yes | No | |
| Results article | results | 20/12/2018 | Yes | No | |
| Results article | results | 01/02/2019 | Yes | No | |
| Results article | results | 01/02/2019 | 15/04/2020 | Yes | No |
| Protocol article | protocol | 12/10/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/04/2020: Publication reference added.
23/01/2019: Publication reference added.
03/01/2019: Publication reference added.
