NCT03480555

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

Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: Feasibility Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: King Abdullah International Medical Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Replenish Protein	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	Standard protein	Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Timeline

• Start date: 2018-05-16
• Primary completion: 2019-05-10
• Completion: 2019-09-10
• First posted: 2018-03-29
• Last updated: 2021-01-05

Locations

2 sites across 1 country: Saudi Arabia