Clinical trial NCT03480555: Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients
Official title: Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
ARDS
Septic Shock
Multiple Trauma
Seizure Disorder
Hemorrhagic Shock
Keywords: Enteral nutrition, Intensive Care Units, caloric restriction, insulin, mortality, protein catabolism
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, we will explore the feasibility of a randomized controlled trial that will compare high protein dose from ICU day 6 to 14 with moderate protein intake.

Detailed description: Patients will be recruited on day 1-2 of ICU admission. On day 5, patients will be randomized into one of the two intervention arms;

Replenish Protein group:

Patients randomized to this group will receive 2 g of protein/kg/day (acceptable range 1.8 - 2.2 g of protein/kg/day) for day 6-14.

Standard Protein group:

Patients randomized to this group will receive protein at 0.8 - 1.0 g of protein/kg/day for day 6-14

Eligibility criteria: Inclusion criteria

1. Age ≥ 18 years
2. Mechanically ventilated
3. Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and
4. Expected to stay ≥ 1 week in the ICU

Exclusion criteria

1. Lack of commitment to ongoing life support, which includes;

   * Terminal Illness (Malignancy or irreversible condition with 6 month mortality \> 50%)
   * DNR order in the first 48 hours and brain death within 48 hours of admission) (Don't include the presence of a "Do Not Resuscitate" order alone, if there is a commitment to ongoing life support).
2. Patients not fed within 48 hours of admission
3. Patients on total parenteral nutrition (TPN)
4. Patients being fed orally
5. Chronic renal failure
6. Chronic liver disease
7. Renal replacement therapy
8. Pregnancy.
9. Kidney transplant
10. Post-liver transplant.
11. Post cardiac arrest.
12. Burn patients.
13. Prisoners

Screened patients will be screened again for eligibility at day 5, should be mechanically ventilated and expected to stay ≥ 3 days in the ICU. At this point, patients will be excluded if they meet the following;

1. New onset renal replacement therapy.
2. Acute Kidney Injury (serum creatinine \> 3 times the preacute level or serum creatinine \>350mmol/L with a recent increase of \>44 mmols/L)
3. Significant liver impairment

Primary outcomes:
measure: Recruitment
timeFrame: 6 months
measure: Retention rate
timeFrame: 14 days
measure: Achieved protein intake
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical city
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical city
Study officials:
affiliation: King Abdulaziz Medical City-Ministry of National Guard
name: Yaseen M Arabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available.
citation: Arabi YM, Aldawood AS, Solaiman O. Permissive Underfeeding or Standard Enteral Feeding in Critical Illness. N Engl J Med. 2015 Sep 17;373(12):1175-6. doi: 10.1056/NEJMc1509259. No abstract available.
citation: Arabi YM, Casaer MP, Chapman M, Heyland DK, Ichai C, Marik PE, Martindale RG, McClave SA, Preiser JC, Reignier J, Rice TW, Van den Berghe G, van Zanten ARH, Weijs PJM. The intensive care medicine research agenda in nutrition and metabolism. Intensive Care Med. 2017 Sep;43(9):1239-1256. doi: 10.1007/s00134-017-4711-6. Epub 2017 Apr 3.
citation: Arabi YM, Al-Dorzi HM, Tamim H, Sadat M, Al-Hameed F, AlGhamdi A, Al Mekhlafi GA, Rasool G, Afesh L, Sakkijha MH, Alamrey NK, Malebari R, Alhutail RH, Al-Dawood A; Saudi Critical Care Trials Group. Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: A pilot randomized controlled trial (REPLENISH pilot trial). Clin Nutr ESPEN. 2021 Aug;44:166-172. doi: 10.1016/j.clnesp.2021.05.008. Epub 2021 Jun 2.