Optimal Protein Supplementation for Critically Ill Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Critical Illness
• Intervention / Treatment: Dietary supplement: Beneprotein

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OUHSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	Time Frame
Mortality	28 days

Other Outcome Measures

Outcome Measure	Time Frame
Number of days in ICU	28 days
Infection Rate	28 days
Discharge location	28 days
New or Significantly worsening skin breakdown	28 days
Mechanical Vent free days	28 days

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Karen S Allen, MD, OUHSC

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (Estimate): September 4, 2013

Study Record Updates

• Last Update Posted (Actual): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: ICU; Protein; Protein synthesis; Critically ill; Supplement
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 3440; SCCM Vision (Other Grant/Funding Number: SCCM Vision Grant)