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

King Abdullah International Medical Research Center

Status: Completed

Conditions: Multiple Trauma; Critical Illness; Hemorrhagic Shock; Seizure Disorder; ARDS; Septic Shock

Treatments: Dietary Supplement: Standard protein; Dietary Supplement: Replenish Protein

Study type: Interventional

Funder types: Other

Identifiers

NCT03480555

RC17/252/R

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Age ≥ 18 years
2. Mechanically ventilated
3. Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and
4. Expected to stay ≥ 1 week in the ICU

Exclusion criteria

1. 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).

2. Patients not fed within 48 hours of admission

3. Patients on total parenteral nutrition (TPN)

4. Patients being fed orally

5. Chronic renal failure

6. Chronic liver disease

7. Renal replacement therapy

8. Pregnancy.

9. Kidney transplant

10. Post-liver transplant.

11. Post cardiac arrest.

12. Burn patients.

13. 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;

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Replenish Protein group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Replenish Protein

Standard Protein group

Other group

Description:

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

Treatment:

Dietary Supplement: Standard protein