Replenish Protein
Dietary SupplementSubjects 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
NCT Number: NCT03480555
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
King Abdulaziz Medical city, Jeddah, Saudi Arabia
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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;
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
Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14
Other names: Control group
Time frame: 6 months
Recruitment log
Time frame: 14 days
withdrawals
Time frame: 14 days
Feeding data
King Abdullah International Medical Research Center
Other
Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: Feasibility Randomized Controlled Trial
Acronym: Replenish
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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