Phase 3
N=500
Supplemental Enteral Protein in Critical Illness
Nutrition Disorder · Trauma · Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT03170401 ↗Enrolled (actual)
500
Serious AEs
18.6%
Results posted
Jun 2024
Primary outcome: Primary: Serum Concentrations of Transthyretin at 3 Weeks After Injury. — 18.1; 18.9 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Protein supplementation (Dietary_supplement); Standard enteral nutrition (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Dec 2022
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 | — |
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.
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.
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.