Phase 3 Completed N=500 Randomized Triple-blind Prevention

Supplemental Enteral Protein in Critical Illness

Nutrition Disorder · Trauma · Critical Illness

Source: ClinicalTrials.gov NCT03170401 ↗

Enrolled (actual)

500

Serious AEs

18.6%

Results posted

Jun 2024

Primary outcomePrimary: Serum Concentrations of Transthyretin at 3 Weeks After Injury. — 18.1; 18.9 mg/dl

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Concentrations of Transthyretin at 3 Weeks After Injury.	18.1; 18.9	—
SECONDARY Ventilator-free Days.	15.0; 13.9	—
SECONDARY Ventilator Associated Pneumonia.	58; 45	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03170401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.