Permissive underfeeding versus target enteral feeding in adult critically ill patients

ISRCTN	ISRCTN68144998
DOI	https://doi.org/10.1186/ISRCTN68144998
Secondary identifying numbers	RC08/040

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

Not provided at time of registration

Contact information

Dr Yaseen Arabi MD, FCCP, FCCM
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
Email	yaseenarabi@yahoo.com

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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 hypothesis	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
Condition	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	90 day-all cause mortality: death before or at day 90 of enrolment
Secondary outcome measures	1. ICU mortality: death in the ICU during the same ICU admission 2. Hospital mortality: death in the hospital (in ICU or on floor) during the same hospital admission 3. 180-day mortality: death before or at day 180 of enrolment 4. Daily Sequential Organ Failure Assessment (SOFA) scores recorded on days 1, 3, 7, 14, 21 and 28
Overall study start date	01/06/2009
Overall study end date	30/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	892
Participant 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
Participant 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
Recruitment start date	01/06/2009
Recruitment end date	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

Sponsor information

King Abdullah International Medical Research Center (KAIMRC) (Saudi Arabia)
Hospital/treatment centre

National Guard Health Affairs
King Saud Bin Abdulaziz University for Health Sciences
King Abdulaziz Medical City
Riyadh
11426
Saudi Arabia

Phone	+966 (0)1 252 0088 ext. 16593
Email	CLNresearch1@ngha.med.sa
Website	http://kaimrc.info/
"ROR"	https://ror.org/009p8zv69

Funders

Funder type

Research organisation

King Abdullah International Medical Research Center (KAIMRC) (Saudi Arabia)

No information available

King Abdul Aziz Medical City (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?
Protocol article	protocol	12/10/2012		Yes	No
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

Editorial Notes

15/04/2020: Publication reference added.
23/01/2019: Publication reference added.
03/01/2019: Publication reference added.