Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2009
Date assigned
24/06/2009
Last edited
25/06/2015
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 MD, FCCP, FCCM

ORCID ID

Contact details

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
+966 (0)1 252 0088 ext. 18855
yaseenarabi@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RC08/040

Study information

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

Acronym

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

Institutional Review Board of the National Guard Health Affairs, King Abdul Aziz Medical City, 08/04/2009, ref: IRBC/017/09

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2009

Overall trial end date

30/12/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

892

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

Trial participating centre

King Saud Bin Abdulaziz University for Health Sciences
Riyadh
11426
Saudi Arabia

Sponsor information

Organisation

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

Sponsor details

National Guard Health Affairs
King Saud Bin Abdulaziz University for Health Sciences
King Abdulaziz Medical City
Riyadh
11426
Saudi Arabia
+966 (0)1 252 0088 ext. 16593
CLNresearch1@ngha.med.sa

Sponsor type

Hospital/treatment centre

Website

http://kaimrc.info/

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

King Abdul Aziz Medical City (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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23057605
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25992505

Publication citations

  1. Protocol

    Arabi YM, Haddad SH, Aldawood AS, Al-Dorzi HM, Tamim HM, Sakkijha M, Jones G, McIntyre L, Mehta S, Solaiman O, Sadat M, Afesh L, Sami B, Permissive underfeeding versus target enteral feeding in adult critically ill patients (PermiT Trial): a study protocol of a multicenter randomized controlled trial., Trials, 2012, 13, 191, doi: 10.1186/1745-6215-13-191.

  2. Results

    Arabi YM, Aldawood AS, Haddad SH, Al-Dorzi HM, Tamim HM, Jones G, Mehta S, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Afesh L; PermiT Trial Group, Permissive Underfeeding or Standard Enteral Feeding in Critically Ill Adults, N Engl J Med, 2015, 372, 25, 2398-2408, doi: 10.1056/NEJMoa1502826.

Additional files

Editorial Notes