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Increasing Enteral Protein Intake in Critically Ill Trauma and Surgical Patients

Primary Purpose

Critical Illness, Malnutrition, Enteral Nutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modular enteral protein - Prosource
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

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

Inclusion Criteria:

  • All critically ill adult trauma (blunt and penetrating) and all surgical critical care patients ≥ 18 years old patients where enteral nutrition is begun by the attending physician during the first 48 hours after injury, and are 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 due to the severity of their illness or traumatic injuries
  • Intestinal discontinuity
  • Short bowel syndrome
  • Bowel obstruction
  • Enterocutaneous fistula
  • Intestinal ischemia
  • Massive gastrointestinal hemorrhage
  • Inability to obtain enteral access

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Modular enteral protein - Prosource

    Control group

    Arm Description

    Subjects are patients admitted to the surgical intensive care unit and identified by one of the investigators as being appropriate for protein supplementation. Guidelines required that patients were: 1. Deemed ready to start enteral nutritional support by the attending physician within 72 hours of admission to the intensive care unit, 2. No contraindications to full enteral support, 3. No history of chronic liver disease, 4. Serum creatinine < 2.0 mg/dl.

    The investigators used the electronic medical record to identify control subjects. These were patients admitted to the surgical intensive care unit who were in the ICU long enough to undergo testing of 24 hour urine nitrogen excretion from January to December 2016.8 As part of standard clinical practice, measurement of urine nitrogen excretion is performed in patients who are in the ICU and receiving nutritional support for more than one week.

    Outcomes

    Primary Outcome Measures

    Enteral protein intake
    Amount of enteral protein intake during first 14 days
    Total urine nitrogen excretion
    Nitrogen excreted in urine over 24 hour period

    Secondary Outcome Measures

    Ventilator-free days
    Days alive and not receiving mechanical ventilation in initial 28 days

    Full Information

    First Posted
    November 5, 2018
    Last Updated
    November 6, 2018
    Sponsor
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03733782
    Brief Title
    Increasing Enteral Protein Intake in Critically Ill Trauma and Surgical Patients
    Official Title
    Increasing Enteral Protein Intake in Critically Ill Trauma and Surgical Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    September 30, 2016 (Actual)
    Study Completion Date
    September 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington

    4. Oversight

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

    5. Study Description

    Brief Summary
    Published guidelines recommend at least 2 gm/kg/day of protein for critically ill surgical patients. It may not be possible to achieve this level of intake using polymeric enteral nutritional formula and protein or amino acid supplementation will be necessary. This was a retrospective cohort study in which the investigators reviewed critically ill trauma and surgical patients treated with supplemental enteral protein according to a protocol aimed to deliver a total of 2 gm/kg/day of protein. The investigators studied detailed nutritional data from a 2 week period after admission and obtained additional data through discharge to determine caloric intake, protein intake and complications. The investigators also compared urine nitrogen excretion and visceral protein (transthyretin) concentrations between those who received early supplementation with those who did not.
    Detailed Description
    This is a retrospective analysis of a treatment approach designed to increase enteral protein intake in critically ill surgical patients. The study investigators recently developed guidelines aimed to improve early enteral protein delivery in critically ill patients. The guidelines were tested for 6 months; applying it to 53 patients (April to September, 2016) in order to determine its safety and effectiveness. All subjects were admitted to the surgical intensive care unit and identified by one of the investigators as being appropriate for protein supplementation. The guidelines required that patients were: 1. Deemed ready to start enteral nutritional support by the attending intensivist within 72 hours of admission to the intensive care unit, 2. No contraindications to full enteral support, 3. No history of chronic liver disease, 4. Serum creatinine <2.0 mg/dl. In order to compare biochemical markers of nutritional support, the investigators used the electronic medical record to identify all patients admitted to the surgical intensive care unit who were in the ICU long enough to undergo testing of 24 hour urine nitrogen excretion from January to December 2016.8 As part of standard clinical practice, measurement of urine nitrogen excretion is performed in patients who are in the ICU and receiving nutritional support for more than one week. In addition to measuring TUN, the investigators also monitor the response to nutritional support and recovery from critical illness using serum transthyretin (also known as prealbumin). This review resulted in a cohort of 118 patients who underwent at least one TUN measurement. Of these, 27 received early protein supplementation and 91 did not and these provide the basis for the comparisons described below. We wanted to measure the effect of early supplemental protein treatment on nitrogen excretion and on serum transthyretin concentrations as the patients recovered. We therefore, compared nitrogen excretion and serum transthyretin between those who received early supplementation and those who did not.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness, Malnutrition, Enteral Nutrition, Protein Supplementation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    118 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Modular enteral protein - Prosource
    Arm Type
    Active Comparator
    Arm Description
    Subjects are patients admitted to the surgical intensive care unit and identified by one of the investigators as being appropriate for protein supplementation. Guidelines required that patients were: 1. Deemed ready to start enteral nutritional support by the attending physician within 72 hours of admission to the intensive care unit, 2. No contraindications to full enteral support, 3. No history of chronic liver disease, 4. Serum creatinine < 2.0 mg/dl.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The investigators used the electronic medical record to identify control subjects. These were patients admitted to the surgical intensive care unit who were in the ICU long enough to undergo testing of 24 hour urine nitrogen excretion from January to December 2016.8 As part of standard clinical practice, measurement of urine nitrogen excretion is performed in patients who are in the ICU and receiving nutritional support for more than one week.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Modular enteral protein - Prosource
    Intervention Description
    Supplemental protein (2 gm/kg/day of Prosource; Medtrition, Lancaster, PA) was administered via the nasal/oral feeding tube in 60 - 180 ml bolus infusions 2 - 4 times per day, independently of the enteral formula received. That is, the daily target amount of protein was initially administered as the supplement boluses and only after the enteral formula infusion approached the target rate was the amount of supplement decreased. Supplemental protein was reduced by 50% once the patient received 75% of targeted caloric intake over the previous day (0700 - 0700). Once the patient reached the target caloric intake for 48 hours, the amount of supplemental protein was decreased in order that the total protein prescribed equaled 2 gm/kg/day.
    Primary Outcome Measure Information:
    Title
    Enteral protein intake
    Description
    Amount of enteral protein intake during first 14 days
    Time Frame
    14 days
    Title
    Total urine nitrogen excretion
    Description
    Nitrogen excreted in urine over 24 hour period
    Time Frame
    up to 2 weeks after admission
    Secondary Outcome Measure Information:
    Title
    Ventilator-free days
    Description
    Days alive and not receiving mechanical ventilation in initial 28 days
    Time Frame
    Up to 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All critically ill adult trauma (blunt and penetrating) and all surgical critical care patients ≥ 18 years old patients where enteral nutrition is begun by the attending physician during the first 48 hours after injury, and are 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 due to the severity of their illness or traumatic injuries Intestinal discontinuity Short bowel syndrome Bowel obstruction Enterocutaneous fistula Intestinal ischemia Massive gastrointestinal hemorrhage Inability to obtain enteral access

    12. IPD Sharing Statement

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    Increasing Enteral Protein Intake in Critically Ill Trauma and Surgical Patients

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