Optimal Protein Supplementation for Critically Ill Patients

Study Overview
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Brief Summary
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It is well accepted that during critical illness there is an increase in protein breakdown and loss of lean body mass. Previous studies have shown that during critical illness muscle breakdown increases dramatically. The aim of our study is to test the hypothesis that critically ill patients have improved outcomes with higher protein supplementation.

Official Title
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Optimal Protein Supplementation for Critically Ill Patients

Conditions
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Critical Illness

Intervention / Treatment
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* Dietary Supplement: Beneprotein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Medical or surgical patients who are admitted or transferred to the ICU with an APACHE II score greater than or equal to 18 and who are candidates for enteral nutrition within 48 hours of admission. Exclusion Criteria: • Patients who cannot tolerate enteral nutrition Patients who have a contraindication for enteral nutrition per American Society of Enteral and Parenteral Nutrition guidelines (GI obstruction, intractable nausea and/or vomiting, short bowel syndrome, distal GI fistula, GI bleeding that will require endoscopy, malabsorption that requires TPN, inability to access the GI tract Patients with chronic stage III or IV kidney disease and/or patients receiving dialysis within six months of this hospital admission as these patients are known to require specific protein diets as an outpatient. Patients with acute kidney injury will not be excluded as there is no evidence to suggest these patients require a specific protein diet secondary to their acute kidney injury. Patients with refractory hypotension unresponsive to vasoactive medications Patients who are unlikely to survive the next 48 hours at the time of enrollment (this will be judged by the treating physician) Patients who are unable to give consent and do not have a family member able to give consent on his/her behalf. Patients with end stage liver disease or undergoing liver transplant or liver resection surgery Patients whose physician thinks he/she should not participate Prisoners Pregnant women (all female of childbearing age will have a urine pregnancy test prior to randomization)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varying amounts of Beneprotein<br>1.5grams/kg/day, 2.0 grams/kg/day, and 2.5 grams/kg, day | Dietary Supplement: Beneprotein<br>* The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.<br>|
| Active Comparator: 1 Gram - Standard Therapy given in ICU<br>1 gram/kg/day of protein | Dietary Supplement: Beneprotein<br>* The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Organ failure free days | The primary outcome will be cumulative organ failure free days (defined as no aggressive medical support for the patient's vital organ systems; including cardiovascular, respiratory, renal, bone marrow, and liver. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critically ill, Protein, Supplement, ICU, Protein synthesis