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

Not Applicable

Completed

• Conditions: Septic Shock; Seizure Disorder; Critical Illness; ARDS; Multiple Trauma; Hemorrhagic Shock
• Interventions: Dietary Supplement: Standard protein; Dietary Supplement: Replenish Protein

• Registration Number: NCT03480555
• Lead Sponsor: King Abdullah International Medical Research Center

Brief 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

Study Timeline

• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-29
• Study Start: 2018-05-16
• Primary Completion: 2019-05-10
• Study Completion: 2019-09-10
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Protein group	Standard protein	Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14
Replenish Protein group	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.

Primary Outcome Measures

Name	Time	Method
Achieved protein intake	14 days	Feeding data
Recruitment	6 months	Recruitment log
Retention rate	14 days	withdrawals

Trial Locations

Locations (1)

King Abdulaziz Medical city; 🇸🇦 Riyadh, Saudi Arabia