Increasing Enteral Protein Intake in Critically Ill Trauma and Surgical Patients

NCT03733782 | Completed

• 1 other identifier: STUDY00002185
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Illness; Malnutrition; Enteral Nutrition; Protein Supplementation

Outcome Measures

Primary Outcomes (2)

• Enteral protein intake

  Amount of enteral protein intake during first 14 days

  14 days

• Total urine nitrogen excretion

  Nitrogen excreted in urine over 24 hour period

  up to 2 weeks after admission

Secondary Outcomes (1)

• Ventilator-free days

  Up to 28 days

Study Arms (2)

Modular enteral protein - Prosource

ACTIVE COMPARATOR

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.

Dietary Supplement: Modular enteral protein - Prosource

Control group

NO INTERVENTION

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.

Interventions

Modular enteral protein - Prosource DIETARY_SUPPLEMENT

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.

Modular enteral protein - Prosource

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

MeSH Terms

Conditions

Critical Illness; Malnutrition

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: April 1, 2016
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: November 7, 2018

Record last verified: 2018-11