Trauma Screening and Supplementation
Improving Preoperative Screening and Postoperative Nutrition in Trauma Patients: Does it Decrease Muscle Wasting or Complications
1 other identifier
interventional
400
1 country
1
Brief Summary
The purpose of the proposed study is twofold: 1) The investigators will evaluate ultrasound imaging to screen trauma patients to identify patients at increased risk of postoperative complications associated with sarcopenia. 2) The investigators will evaluate a commercially-available oral nutritional supplement that has previously been evaluated in critically-ill intensive care patients and shown benefit for decreasing complications including decreased wound healing complications, decreased pressure ulcers, decreased skeletal muscle loss due to immobilization, and decreased one-year mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2018
CompletedFirst Submitted
Initial submission to the registry
August 31, 2018
CompletedFirst Posted
Study publicly available on registry
September 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2019
CompletedSeptember 21, 2023
September 1, 2023
1.7 years
August 31, 2018
September 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in body composition
Change in muscle mass
One year
Secondary Outcomes (2)
Change in hand grip strength
One year
Number of participants with post-operative complications
One year
Study Arms (2)
Nutritional supplement group
EXPERIMENTALSubjects in this group will be asked to consume the nutritional supplement on a daily basis, in addition to standard nutrition. Subjects will have pain medication and postoperative therapies per standard of care.
Standard nutrition group
NO INTERVENTIONSubjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care.
Interventions
Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations
Eligibility Criteria
You may qualify if:
- Diagnosis of acute fracture of the upper extremity, pelvis, or lower extremity with plans for operative fixation
You may not qualify if:
- Patients with comorbidities excluding the use of proposed nutritional supplement (phenylketonuria, galactoseria)
- Patients with major head trauma
- Pregnant women
- Dementia
- Vulnerable populations (minors, prisoners)
- Lack of decision making capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael C Willeylead
- Orthopaedic Trauma Associationcollaborator
Study Sites (1)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Hendrickson, MD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 31, 2018
First Posted
September 5, 2018
Study Start
March 15, 2018
Primary Completion
November 13, 2019
Study Completion
November 13, 2019
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share