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Completed

NCT Number: NCT03480555

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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;

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

Treatment and study plan

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.

Other names: Intervention group

Standard protein

Dietary Supplement

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

Other names: Control group

Primary outcomes

  1. Recruitment

    Time frame: 6 months

    Recruitment log

  2. Retention rate

    Time frame: 14 days

    withdrawals

  3. Achieved protein intake

    Time frame: 14 days

    Feeding data

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: Feasibility Randomized Controlled Trial

Acronym: Replenish

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Jan 5, 2021

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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