Increasing Enteral Protein Intake in Critically Ill Trauma and Surgical Patients

Not Applicable

Completed

• Conditions: Critical Illness; Malnutrition; Enteral Nutrition; Protein Supplementation
• Interventions: Dietary Supplement: Modular enteral protein - Prosource

• Registration Number: NCT03733782
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2018-11
• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Study First Posted: 2018-11-07
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modular enteral protein - Prosource	Modular enteral protein - Prosource	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.

Primary Outcome Measures

Name	Time	Method
Enteral protein intake	14 days	Amount of enteral protein intake during first 14 days
Total urine nitrogen excretion	up to 2 weeks after admission	Nitrogen excreted in urine over 24 hour period

Secondary Outcome Measures

Name	Time	Method
Ventilator-free days	Up to 28 days	Days alive and not receiving mechanical ventilation in initial 28 days