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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Critical Illness, ARDS, Septic Shock, Multiple Trauma, Seizure Disorder, Hemorrhagic Shock

Intervention / Treatment
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* Dietary Supplement: Replenish Protein
* Dietary Supplement: Standard protein


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Replenish Protein group<br>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<br>* 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.<br>* Other names: Intervention group;|
| Other: Standard Protein group<br>Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14 | Dietary Supplement: Standard protein<br>* Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Recruitment log | 6 months | 
| Retention rate | withdrawals | 14 days | 
| Achieved protein intake | Feeding data | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral nutrition, Intensive Care Units, caloric restriction, insulin, mortality, protein catabolism