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Trauma Screening and Supplementation

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ClinicalTrials.gov Identifier: NCT03658278
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
Nathan Hendrickson, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Trauma Nutritional Deficiency Wound Heal Dietary Supplement: Juven Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Improving Preoperative Screening and Postoperative Nutrition in Trauma Patients: Does it Decrease Muscle Wasting or Complications
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutritional supplement group
Subjects 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.
Dietary Supplement: Juven
Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations

No Intervention: Standard nutrition group
Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care.



Primary Outcome Measures :
  1. Change in body composition [ Time Frame: One year ]
    Change in muscle mass


Secondary Outcome Measures :
  1. Change in hand grip strength [ Time Frame: One year ]
    Change in hand grip strength as measured by hand held dynamometer

  2. Number of participants with post-operative complications [ Time Frame: One year ]
    Medical and surgical complications following operative fracture fixation, validated patient reported outcome measures, radiographic measures of fracture healing, time spent in hospital, discharge status (home versus acute rehabilitation versus skilled nursing facility)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of acute fracture of the upper extremity, pelvis, or lower extremity with plans for operative fixation

Exclusion Criteria:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658278


Contacts
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Contact: Nathan Hendrickson, MD 319-384-8452 nathan-hendrickson@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Nathan Hendrickson, MD    319-384-8452    nathan-hendrickson@uiowa.edu   
Principal Investigator: Nathan Hendrickson, MD         
Sponsors and Collaborators
Nathan Hendrickson
Orthopaedic Trauma Association
Investigators
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Principal Investigator: Nathan Hendrickson, MD University of Iowa

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Responsible Party: Nathan Hendrickson, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03658278     History of Changes
Other Study ID Numbers: 201706789
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Malnutrition
Nutrition Disorders