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NCT Number: NCT04475666

Replacing Protein Via Enteral Nutrition in Critically Ill Patients

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 day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.

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Key information

Conditions

Critical Illness Disease Attributes Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz Medical city, Jeddah, Saudi Arabia

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About this study

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 ICU day 4, protein requirement will be provided according to the local practice as long as no intravenous amino acids are given and the average protein intake in the first 4 days does not exceed 0.8 g/kg/day. On ICU day 4, patients will be randomized to one of the two treatment groups: one with standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula and another group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula AND supplemental protein at 1.2 g/kg/day.

Randomization will be stratified by suspected COVID-19 and then by site and the use of renal replacement therapy at the time of randomization (intermittent hemodialysis or continuous renal replacement therapy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Replenish protein group

Other

For patients with Body mass index(BMI) <30, use pre-ICU actual body weight(BW) for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight

Standard protein group

Other

For patients with BMI <30, use pre-ICU actual BW for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight

Primary outcomes

  1. 90 day-all cause mortality

    Time frame: 90 days

    Mortality 90 days post randomization

Secondary outcomes

  1. Days alive at day 90 without life support

    Time frame: 90 days

    use of vasopressor/inotropic support, invasive mechanical ventilation and/or renal replacement therapy

  2. Days alive and out of hospital at day 90

    Time frame: 90 days

    90 day survival after randomization

  3. Bacteremia until 2 days of ICU stay

    Time frame: until 2 days post ICU.

    Any symptoms of bacteremia

  4. New or progression of Skin Pressure Ulcers

    Time frame: ICU stay

    anytime during ICU stay

  5. Functional assessment at day 90

    Time frame: Day 90

    SARC-F screen for sarcopenia and EuroQoL

Other outcomes

  1. Safety outcomes during ICU stay

    Time frame: ICU stay

    New episode of stage 2 or higher AKI by KDIGO criteria; 2. Pneumonia defined as episodes of newly confirmed pneumonia according to the modified CDC criteria; 3. Grade IV Acute Gastrointestinal injury (AGI)

  2. Minor safety outcomes during ICU stay

    Time frame: ICU stay

    Feeding tolerance; Diarrhoea; Refeeding syndrome

Study contacts

Contact information is provided by the study sponsor or research team.

Musharaf Sadat, MBBS

CONTACT

[email protected]

0118011111 ext. 10822

Yaseen M Arabi, MD

CONTACT

[email protected]

0118011111 ext. 18855

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Registry information

Official study title

Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: An International, Multicenter Randomized Controlled Trial

Acronym: REPLENISH

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jul 17, 2020
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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