Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients

NCT03480555 | Completed DMC

• 1 other identifier: RC17/252/R
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Illness; ARDS; Septic Shock; Multiple Trauma; Seizure Disorder; Hemorrhagic Shock

Keywords

Enteral nutrition, Intensive Care Units, caloric restriction, insulin, mortality, protein catabolism

Outcome Measures

Primary Outcomes (3)

• Recruitment

  Recruitment log

  6 months

• Retention rate

  withdrawals

  14 days

• Achieved protein intake

  Feeding data

  14 days

Study Arms (2)

Replenish Protein group

ACTIVE COMPARATOR

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

Dietary Supplement: Replenish Protein

Standard Protein group

OTHER

Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Dietary Supplement: Standard protein

Interventions

Replenish Protein DIETARY_SUPPLEMENT

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

Also known as: Intervention group

Replenish Protein group

Standard protein DIETARY_SUPPLEMENT

Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Also known as: Control group

Standard Protein group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• Patients not fed within 48 hours of admission
• Patients on total parenteral nutrition (TPN)
• Patients being fed orally
• Chronic renal failure
• Chronic liver disease
• Renal replacement therapy
• Pregnancy.
• Kidney transplant
• Post-liver transplant.
• Post cardiac arrest.
• Burn patients.
• Prisoners

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (2)

King Abdulaziz Medical city

Jeddah, 21423, Saudi Arabia

Location

King Abdulaziz Medical city

Riyadh, 11426, Saudi Arabia

Location

Related Publications (4)

• 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.

  PMID: 26773077 RESULT

• 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.

  PMID: 26376142 RESULT

• 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.

  PMID: 28374096 RESULT

• 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.

  PMID: 34330462 DERIVED

MeSH Terms

Conditions

Critical Illness; Shock, Septic; Multiple Trauma; Epilepsy; Shock, Hemorrhagic; Insulin Resistance

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yaseen M Arabi, MD

  King Abdulaziz Medical City-Ministry of National Guard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 29, 2018
• Study Start: May 16, 2018
• Primary Completion: May 10, 2019
• Study Completion: September 10, 2019
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)