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Supplemental Enteral Protein in Critical Illness

Primary Purpose

Nutrition Disorder, Trauma, Critical Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein supplementation
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nutrition Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • Critically ill adult trauma (blunt and penetrating) victims
  • Other critically ill surgical patients
  • enteral nutrition required during the first 96 hours after injury
  • expected to require nutritional support for at least 1 week

Exclusion Criteria:

  • Significant chronic organ failure,
  • severe malnutrition pre-existing prior to ICU admission
  • not expected to survive from their traumatic injuries.
  • intestinal discontinuity
  • short bowel syndrome
  • bowel obstruction
  • enterocutaneous fistula
  • intestinal ischemia
  • massive gastrointestinal hemorrhage
  • inability to obtain enteral access.

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

no protein supplementation

protein supplementation

Arm Description

trauma subjects receiving enteral nutrition without any protein supplementation

trauma subjects receiving enteral nutrition with additional protein supplementation

Outcomes

Primary Outcome Measures

Serum concentrations of transthyretin at 3 weeks after injury.
Transthyretin is a circulating biomarker of nutritional status and protein synthesis.

Secondary Outcome Measures

Ventilator-free days.
Ventilator-free days will measured in the standard way and indicate the number of days a subject was alive and not receiving mechanical ventilation during the first 28 days.
Hospital-acquired pneumonia
Pneumonia diagnosed while the patient is in the hospital.

Full Information

First Posted
April 18, 2017
Last Updated
March 30, 2023
Sponsor
University of Washington
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03170401
Brief Title
Supplemental Enteral Protein in Critical Illness
Official Title
Protein-enhanced Enteral Nutrition and Metabolomics in Critically Ill Trauma and Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is too determine the effect of enteral protein supplementation on biochemical measures of inflammation and protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness. Hypothesis: That early supplemental protein will increase serum concentrations of transthyretin at three weeks after the onset of illness or injury. Secondarily, the investigators will test whether supplementation, reduces infectious complications and increases ventilator-free days.
Detailed Description
Critically ill patients are frequently undernourished. The investigator's observations indicate that surgical and trauma patients who require artificial nutrition are likely to be markedly undernourished during the first week of critical illness, will often require intensive and costly support for organ failure, have prolonged stays in the intensive care unit and extended hospitalizations. Nitrogen deficits are typically greater and receive less attention than caloric deficits. In some respects, the focus on avoiding caloric deficits may have missed the mark. A broader consideration of nutrient needs, such as protein, is required. For instance, there are observational data supporting the notion that protein intake is at least as important as caloric intake in promoting recovery in critical illness. Only recently have national guidelines (ASPEN 2016) begun to specifically address protein requirements (1.5 - 2.0 g/kg/day). For a number of years, the approach to these critically ill patients has included weekly measurements of 24 hour urine nitrogen excretion in order to better understand the protein deficits that develop. Based upon physician preference, the investigators can then use enteral protein supplementation to match the urinary nitrogen excretion in order to achieve net "zero" nitrogen balance. With supplemental protein administration, physicians are able to reduce this deficit and in some cases, generate a positive nitrogen balance. However, there are no data to indicate that this approach (which is included as part of the 2016 ASPEN guidelines) improves clinical outcomes. The most obvious mechanism whereby supplemental protein may influence outcomes by providing more metabolic substrate for protein building. Feeding the gut likely creates a more anabolic environment and additional protein may facilitate anabolism. However, it is not known whether protein supplementation improves markers of anabolism and protein synthesis. In this study, the investigators will measure the anabolic effect of supplemental protein by following serum transthyretin concentrations as part of the standard clinical care.The investigators postulate that supplemental protein will attenuate the drop in comparison to no supplemental protein and will hasten the return to normal concentrations. The proposed study will test whether early, and standardized protein supplementation: (1) Increases protein delivery during the first 2 weeks after injury, (2) increases serum transthyretin concentrations at 3 weeks after injury (3) increases ventilator-free days. Study aims: The aim of this study is to determine the effect of enteral protein supplementation on biochemical measures of protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness. However, this study will not enroll a sufficient number of subjects to adequately test for differences in these clinical end-points. Hypothesis: That early supplemental protein will, increase serum concentrations of transthyretin at three weeks after injury. Secondarily, the investigators will test whether supplementation reduces infectious complications and increases ventilator-free days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorder, Trauma, Critical Illness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no protein supplementation
Arm Type
No Intervention
Arm Description
trauma subjects receiving enteral nutrition without any protein supplementation
Arm Title
protein supplementation
Arm Type
Active Comparator
Arm Description
trauma subjects receiving enteral nutrition with additional protein supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplementation
Intervention Description
half the subjects will receive protein supplementation via enteral feedings and half will not receive the protein supplementation
Primary Outcome Measure Information:
Title
Serum concentrations of transthyretin at 3 weeks after injury.
Description
Transthyretin is a circulating biomarker of nutritional status and protein synthesis.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Ventilator-free days.
Description
Ventilator-free days will measured in the standard way and indicate the number of days a subject was alive and not receiving mechanical ventilation during the first 28 days.
Time Frame
1 year
Title
Hospital-acquired pneumonia
Description
Pneumonia diagnosed while the patient is in the hospital.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Critically ill adult trauma (blunt and penetrating) victims Other critically ill surgical patients enteral nutrition required during the first 96 hours after injury expected to require nutritional support for at least 1 week Exclusion Criteria: Significant chronic organ failure, severe malnutrition pre-existing prior to ICU admission not expected to survive from their traumatic injuries. intestinal discontinuity short bowel syndrome bowel obstruction enterocutaneous fistula intestinal ischemia massive gastrointestinal hemorrhage inability to obtain enteral access.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant O'Keefe, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Supplemental Enteral Protein in Critical Illness

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