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Optimal Protein Supplementation for Critically Ill Patients

Primary Purpose

Critical Illness

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beneprotein
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Critically ill, Protein, Supplement, ICU, Protein synthesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • OUHSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Varying amounts of Beneprotein

1 Gram - Standard Therapy given in ICU

Arm Description

1.5grams/kg/day, 2.0 grams/kg/day, and 2.5 grams/kg, day

1 gram/kg/day of protein

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality

Full Information

First Posted
August 29, 2013
Last Updated
June 6, 2017
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT01934595
Brief Title
Optimal Protein Supplementation for Critically Ill Patients
Official Title
Optimal Protein Supplementation for Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Critically ill, Protein, Supplement, ICU, Protein synthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varying amounts of Beneprotein
Arm Type
Experimental
Arm Description
1.5grams/kg/day, 2.0 grams/kg/day, and 2.5 grams/kg, day
Arm Title
1 Gram - Standard Therapy given in ICU
Arm Type
Active Comparator
Arm Description
1 gram/kg/day of protein
Intervention Type
Dietary Supplement
Intervention Name(s)
Beneprotein
Intervention Description
The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.
Primary Outcome Measure Information:
Title
Cumulative Organ failure free days
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Number of days in ICU
Time Frame
28 days
Title
Infection Rate
Time Frame
28 days
Title
Discharge location
Time Frame
28 days
Title
New or Significantly worsening skin breakdown
Time Frame
28 days
Title
Mechanical Vent free days
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen S Allen, MD
Organizational Affiliation
OUHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
OUHSC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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Optimal Protein Supplementation for Critically Ill Patients

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