CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 500 enrolled
Drug / intervention
Protein supplementation +1 moredietary
Likely dose
Not stated in record
Key inclusion· 4
  • Critically ill adult trauma victims (blunt or penetrating)
  • Other critically ill surgical patients
  • Enteral nutrition required within first 96 hours after injury
  • Expected to require nutritional support for at least 1 week
Key exclusion· 10
  • Significant chronic organ failure
  • Severe pre-existing malnutrition prior to ICU admission
  • Not expected to survive from traumatic injuries
  • Intestinal discontinuity

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03170401
NCT03170401Phase 3Completed

Protein-enhanced Enteral Nutrition and Metabolomics in Critically Ill Trauma and Surgical Patients

University of Washington·interventional·Posted May 31, 2017·Updated Jun 5, 2024

In Brief

A Phase 3 clinical trial evaluating Protein supplementation and Standard enteral nutrition for Nutrition Disorder and 2 related conditions. Completed, enrolled 500 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 31, 2017
Enrollment StartNov 1, 2016
Primary CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 9.1 years ago

Interventions

Protein supplementationdietary

enteral protein supplementation

Standard enteral nutritionother

Standard enteral nutrition.