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Status:

RECRUITING

Replacing Protein Via Enteral Nutrition in Critically Ill Patients

Lead Sponsor:

King Abdullah International Medical Research Center

Conditions:

Critical Illness

Nutrition Disorders

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU da...

Detailed Description

The REPLENISH is a multicentric, international, open label, randomized controlled trial which will enroll subjects in intensive care unit. Patients will be randomized on day 4 of ICU admission. Until ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria(on ICU calendar day 4 or the morning of day 5)
  • Age ≥18-years old
  • Patient started on enteral nutrition (EN) via nasogastric/orogastric or duodenal or percutaneous endoscopic gastrostomy (PEG) or jejunostomy tubes.
  • The patient is on invasive mechanical ventilation and unlikely to be discharged from ICU next day.
  • Exclusion Criteria:
  • Lack of commitment to full life support or brain death. Patients with "Do Not Resuscitate" order but with commitment to ongoing life support can be enrolled.
  • Patients on any amount of parenteral nutrition (PN) in ICU at the time of screening, whether PN is used alone or in combination with enteral nutrition. Non-nutritional calories (dextrose, propofol, citrate) not considered as PN.
  • Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
  • Patients being fed entirely through oral route - i.e. those who are eating.
  • Pregnancy.
  • Burn patients.
  • Prisoners or those undergoing forced treatment.
  • Patients with hepatic encephalopathy or Child C liver cirrhosis
  • Inherited defect of amino acid metabolism.
  • Allergies to protein supplement

Exclusion

    Key Trial Info

    Start Date :

    September 21 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 30 2026

    Estimated Enrollment :

    2502 Patients enrolled

    Trial Details

    Trial ID

    NCT04475666

    Start Date

    September 21 2020

    End Date

    April 30 2026

    Last Update

    September 8 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    King Abdulaziz Medical city

    Jeddah, Jeddah, Saudi Arabia, 21423

    2

    Intensive Care Unit, King Abdulaziz Medical City

    Riyadh, Saudi Arabia, 11426