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

Sponsor

King Abdullah International Medical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT03480555

Collaborator

(none)

Enrollment

Locations

Arms

15.8

Actual Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness ARDS Septic Shock Multiple Trauma Seizure Disorder Hemorrhagic Shock	Dietary Supplement: Replenish Protein Dietary Supplement: Standard protein	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 16, 2018

Actual Primary Completion Date :

May 10, 2019

Actual Study Completion Date :

Sep 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Replenish Protein group 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: 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. Other Names: Intervention group
Other: Standard Protein group Subjects randomized to this group will receive 0.8 - 1 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 Other Names: Control group

Arm

Intervention/Treatment

Active Comparator: Replenish Protein group

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: 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.

Other Names:

Intervention group

Other: Standard Protein group

Subjects randomized to this group will receive 0.8 - 1 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

Other Names:

Control group

Outcome Measures

Primary Outcome Measures

Recruitment [6 months]
Recruitment log
Retention rate [14 days]
withdrawals
Achieved protein intake [14 days]
Feeding data

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;