Critical Illness | Optimal Protein Supplementation for Critically Ill Patients

Critical Illness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critical Illness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:BeneproteinThe study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Varying amounts of Beneprotein1.5grams/kg/day, 2.0 grams/kg/day, and 2.5 grams/kg, day

1 Gram - Standard Therapy given in ICU1 gram/kg/day of protein

Study Status


Start Date: September 2013

Completed Date: September 2017

Phase: N/A

Type: Interventional


Primary Outcome: Cumulative Organ failure free days

Secondary Outcome: Mortality

Study sponsors, principal investigator, and references

Principal Investigator: Karen S Allen, MD

Lead Sponsor: University of Oklahoma


More information:

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