Trial Outcomes & Findings for Supplemental Enteral Protein in Critical Illness (NCT NCT03170401)

NCT ID: NCT03170401

Last Updated: 2024-06-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 500 participants
• Primary outcome timeframe: 3 weeks after admission for injury
• Results posted on: 2024-06-05

Participant Flow

Potential study subjects included those admitted to the trauma and surgical intensive care services at Harborview Medical Center. Patients were screened by a member of the study team and were considered for inclusion if they were receiving mechanical ventilation expected to require ICU care for >7 days, deemed ready to start enteral nutritional support by the attending physician within 24 - 72 hours of admission, and had no contraindications to full enteral support.

No enrolled subjects were excluded prior to assignment to groups.

Participant milestones

Measure	no Protein Supplementation trauma subjects receiving enteral nutrition without any protein supplementation	Protein Supplementation trauma subjects receiving enteral nutrition with additional protein supplementation Protein supplementation: half the subjects will receive protein supplementation via enteral feedings and half will not receive the protein supplementation
Study Subject Enrollment STARTED	256	244
Study Subject Enrollment COMPLETED	256	244
Study Subject Enrollment NOT COMPLETED	0	0
Follow up and Data Analysis STARTED	256	244
Follow up and Data Analysis COMPLETED	256	244
Follow up and Data Analysis NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supplemental Enteral Protein in Critical Illness

Baseline characteristics by cohort

Measure	no Protein Supplementation n=256 Participants trauma and critically ill surgical patients receiving enteral nutrition without any protein supplementation	Protein Supplementation n=244 Participants trauma and critically ill surgical patients receiving enteral nutrition with additional protein supplementation	Total n=500 Participants Total of all reporting groups
Age, Continuous	49 years n=5 Participants	45 years n=7 Participants	47 years n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	60 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	202 Participants n=5 Participants	184 Participants n=7 Participants	386 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	224 Participants n=5 Participants	210 Participants n=7 Participants	434 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	210 Participants n=5 Participants	204 Participants n=7 Participants	414 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	256 participants n=5 Participants	244 participants n=7 Participants	500 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks after admission for injury

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

Outcome measures

Measure	no Protein Supplementation n=129 Participants trauma and critically ill surgical patients receiving enteral nutrition without any protein supplementation	Protein Supplementation n=122 Participants trauma and critically ill surgical patients receiving enteral nutrition with additional protein supplementation
Serum Concentrations of Transthyretin at 3 Weeks After Injury.	18.1 mg/dl Standard Deviation 8.0	18.9 mg/dl Standard Deviation 8.5

SECONDARY outcome

Timeframe: Within 28 days following admission to hospital following injury.

Ventilator-free days will measured in the standard way and indicate the number of days a subject was alive and not receiving mechanical ventilation during the first 28 days.

Outcome measures

Measure	no Protein Supplementation n=256 Participants trauma and critically ill surgical patients receiving enteral nutrition without any protein supplementation	Protein Supplementation n=244 Participants trauma and critically ill surgical patients receiving enteral nutrition with additional protein supplementation
Ventilator-free Days.	15.0 days Standard Deviation 9.7	13.9 days Standard Deviation 9.8

SECONDARY outcome

Timeframe: At any point during the hospitalization.

Pneumonia diagnosed while the patient is receiving mechanical ventilation as recorded in the institutional administrative trauma registry and ICU quality assurance database.

Outcome measures

Measure	no Protein Supplementation n=256 Participants trauma and critically ill surgical patients receiving enteral nutrition without any protein supplementation	Protein Supplementation n=244 Participants trauma and critically ill surgical patients receiving enteral nutrition with additional protein supplementation
Ventilator Associated Pneumonia.	58 Participants	45 Participants

Adverse Events

no Protein Supplementation

Serious events: 31 serious events

Other events: 136 other events

Deaths: 34 deaths

Protein Supplementation

Serious events: 62 serious events

Other events: 164 other events

Deaths: 36 deaths

Serious adverse events

Measure	no Protein Supplementation n=256 participants at risk trauma and critically ill surgical patients receiving enteral nutrition without any protein supplementation	Protein Supplementation n=244 participants at risk trauma and critically ill surgical patients receiving enteral nutrition with additional protein supplementation
Respiratory, thoracic and mediastinal disorders Adjudicated aspiration	2.7% 7/256 • Duration of hospitalization to a maximum of 1 year.	6.1% 15/244 • Duration of hospitalization to a maximum of 1 year.
Respiratory, thoracic and mediastinal disorders Reintubation	8.6% 22/256 • Duration of hospitalization to a maximum of 1 year.	18.9% 46/244 • Duration of hospitalization to a maximum of 1 year.
Gastrointestinal disorders Gastrointestinal perforation	0.78% 2/256 • Duration of hospitalization to a maximum of 1 year.	0.41% 1/244 • Duration of hospitalization to a maximum of 1 year.

Other adverse events

Measure	no Protein Supplementation n=256 participants at risk trauma and critically ill surgical patients receiving enteral nutrition without any protein supplementation	Protein Supplementation n=244 participants at risk trauma and critically ill surgical patients receiving enteral nutrition with additional protein supplementation
Gastrointestinal disorders Diarrhea	37.1% 95/256 • Duration of hospitalization to a maximum of 1 year.	48.8% 119/244 • Duration of hospitalization to a maximum of 1 year.
Gastrointestinal disorders Abdominal distention	7.8% 20/256 • Duration of hospitalization to a maximum of 1 year.	11.1% 27/244 • Duration of hospitalization to a maximum of 1 year.
Gastrointestinal disorders Emesis	8.2% 21/256 • Duration of hospitalization to a maximum of 1 year.	7.4% 18/244 • Duration of hospitalization to a maximum of 1 year.

Additional Information

Dr. Grant E O'Keefe

University of Washingtion

Phone: 206-744-8016

Email: gokeefe@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place