Supplemental Enteral Protein in Critical Illness

NCT03170401 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: STUDY000079181R01GM127790-01A1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Disorder; Trauma; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Serum Concentrations of Transthyretin at 3 Weeks After Injury.

  Transthyretin is a circulating biomarker of nutritional status and protein synthesis.

  3 weeks after admission for injury

Secondary Outcomes (2)

• Ventilator-free Days.

  Within 28 days following admission to hospital following injury.

• Ventilator Associated Pneumonia.

  At any point during the hospitalization.

Study Arms (2)

no protein supplementation

ACTIVE COMPARATOR

subjects receiving enteral nutrition without any protein supplementation

Other: Standard enteral nutrition

protein supplementation

EXPERIMENTAL

subjects receiving enteral nutrition with additional protein supplementation

Dietary Supplement: Protein supplementation

Interventions

Protein supplementation DIETARY_SUPPLEMENT

enteral protein supplementation

protein supplementation

Standard enteral nutrition OTHER

Standard enteral nutrition.

no protein supplementation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Nutrition Disorders; Wounds and Injuries; Critical Illness

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Grant E O'Keefe
• Organization: University of Washingtion

gokeefe@uw.edu

206-744-8016

Study Officials

• Grant O'Keefe, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: May 31, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-05

Locations

US (1)