TraumaNCT03658278
Trauma Screening and Supplementation
A study testing Juven in people with Trauma and Nutritional Deficiency, run by Michael C Willey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Trauma, Nutritional Deficiency, Wound Heal
- What is being tested?
- Juven
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 13 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute fracture of the upper extremity, pelvis, or lower extremity with plans for operative fixation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Improving Preoperative Screening and Postoperative Nutrition in Trauma Patients: Does it Decrease Muscle Wasting or Complications
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.
Read the detailed description
Following consent, patients will be assigned a unique study identification number (ID). A master list linking patient ID to patient name and medical record number will be maintained on a password protected and encrypted departmental server location with access limited to research staff. Patients will be randomized by the research team using Microsoft Word random number generator. Patients will not be blinded to their research group, as the experimental nutrition supplementation group will be asked to consume the nutritional supplement daily for a period of two weeks following surgery.
Following consent, the patient's medical record will be reviewed to identify any condition meeting exclusion criteria. If patient meets inclusion criteria we will obtain the following data to be recorded in the research database.
- Age
- Sex
- Height
- Weight
- BMI
- medical comorbidities necessary to calculate Charlson Comorbidity Index (myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatologic disorder, peptic ulcer disease, diabetes without chronic complications, diabetes with chronic complications, hemiplegia or paraplegia, renal disease, any malignancy, metastatic solid tumor, mild liver disease, moderate or severe liver disease, HIV/AIDS
- MSSA (methicillin-susceptible Staphylococcus aureus) /MRSA (methicillin-resistant Staphylococcus aureus) nasal colonization status (standard preoperative evaluation)
- tobacco use history
- history of DVT (deep vein thrombosis) or PE (pulmonary embolism)
- other injuries associated with current trauma to calculate Injury Severity Score
Patients will be treated with operative fixation of their fracture per standard of care. Within 24 hours of providing informed consent, we will obtain patient weight with a clinical scale or hospital bed equipped with clinical scale. We will obtain body composition using a validated handheld ultrasound device that reports fat mass, fat free mass, and % body fat (BodyMetrix, Intellimatrix, Brentwood, CA). Hand grip strength will be assessed with the patient's dominant hand, or non-dominant hand if unable to perform due to injury (hand dynamometer, Hausmann Industries, Northvale, New Jersey).
Following surgery, patients in the treatment group will be asked to consume the nutritional supplement on a daily basis, in addition to standard nutrition. The control group will have standard nutrition provided per dietitian recommendation. Patients will have pain medication and postoperative therapies per standard of care.
The nutritional supplements will be consumed per manufacturer recommendations. Descriptions of nutritional supplementation are included below.
Juven is an oral nutritional supplement produced by Abbot Nutrition. It is not considered a drug and is not under FDA regulation. Juven has been studied in clinical trials and shown to decrease pressure ulcer occurrence, decrease muscle wasting, and increase collagen deposition in wound healing (10,11).
Juven is packaged as a powder containing 24g per pouch and is mixed with 8-10 fl oz water or juice for consumption. The recommended supplementation schedule is two servings daily in addition to balanced diet.
Nutrient data for Juven obtained from manufacturer's website 7/20/2017: https://abbottnutrition.com/juven Serving size: 24 g (1 packet) L-arginine 7g L-glutamine 7g Carbohydrate 7.9g Sugars 1g Calcium 200mg Calcium beta-hydroxy-beta-methylbutyrate 1.5g
After discharge from the hospital, we will communicate with patients by mobile phone messaging on a daily basis to confirm consumption of the investigative nutritional supplementation. We will also communicate with patients at 3 months, 6 months, 9 months, and 12 months after surgery to inquire about any complications or hospitalizations.
Following surgery, patients will be reevaluated in the orthopedic trauma clinic at routine intervals per standard of care (postoperative visits are typically scheduled at 2 weeks, 6 weeks, 6 months, and 1 year). Patients will be seen in clinic by orthopedic surgery trauma staff. All orthopedic trauma staff are included on the research team. As part of routine clinical follow up visit, research team will review the patient medical record, perform a focused history and physical exam and document any new hospital readmission, medical complication, surgical complication. Radiographs will be obtained per standard orthopedic care to assess fracture healing and no additional radiographs will be obtained for the purpose of this study.
At the patient's first postoperative clinic follow up, we will repeat measures of patient weight, body composition, and hand grip strength. These measures are expected to take less than 15 minutes at the time of their clinic appointment.
Subjects will also be asked to complete several questionnaires via RedCap at several times points during the study. The questionnaires will be completed either in clinic on a tablet or computer, or a secure link to the study will be emailed to subjects.
No data collection is planned after one year from the time of surgery.
- Conditions
- Trauma, Nutritional Deficiency, Wound Heal
- Being tested
- Juven
- Medical subject headings
- Wounds and Injuries, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuvenDietary supplement
Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplement group | Experimental | 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. Receives: Dietary Supplement: Juven |
| Standard nutrition group | No intervention | Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition
Change in muscle mass
Measured: One year
Secondary outcomes (2)
Change in hand grip strength
Change in hand grip strength as measured by hand held dynamometer
Measured: One year
Number of participants with post-operative complications
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)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start15 Mar 2018
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael C Willey
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Sponsor-investigator, Michael C Willey, University of Iowa
- Investigators
- Nathan Hendrickson, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658278
- Sponsor's protocol ID
- 201706789
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Preoperative Screening and Postoperative Nutrition in Trauma Patients: Does it Decrease Muscle Wasting or Complications
- ClinicalTrials.gov ID
- NCT03658278
- Acronym / sponsor ID
- 201706789
- Conditions
- Trauma, Nutritional Deficiency, Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Michael C WilleyUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following consent, patients will be assigned a unique study identification number (ID). A master list linking patient ID to patient name and medical record number will be maintained on a password protected and encrypted departmental server location with access limited to research staff. Patients will be randomized by the research team using Microsoft Word random number generator. Patients will not be blinded to their research group, as the experimental nutrition supplementation group will be asked to consume the nutritional supplement daily for a period of two weeks following surgery.
Following consent, the patient's medical record will be reviewed to identify any condition meeting exclusion criteria. If patient meets inclusion criteria we will obtain the following data to be recorded in the research database.
- Age
- Sex
- Height
- Weight
- BMI
- medical comorbidities necessary to calculate Charlson Comorbidity Index (myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatologic disorder, peptic ulcer disease, diabetes without chronic complications, diabetes with chronic complications, hemiplegia or paraplegia, renal disease, any malignancy, metastatic solid tumor, mild liver disease, moderate or severe liver disease, HIV/AIDS
- MSSA (methicillin-susceptible Staphylococcus aureus) /MRSA (methicillin-resistant Staphylococcus aureus) nasal colonization status (standard preoperative evaluation)
- tobacco use history
- history of DVT (deep vein thrombosis) or PE (pulmonary embolism)
- other injuries associated with current trauma to calculate Injury Severity Score
Patients will be treated with operative fixation of their fracture per standard of care. Within 24 hours of providing informed consent, we will obtain patient weight with a clinical scale or hospital bed equipped with clinical scale. We will obtain body composition using a validated handheld ultrasound device that reports fat mass, fat free mass, and % body fat (BodyMetrix, Intellimatrix, Brentwood, CA). Hand grip strength will be assessed with the patient's dominant hand, or non-dominant hand if unable to perform due to injury (hand dynamometer, Hausmann Industries, Northvale, New Jersey).
Following surgery, patients in the treatment group will be asked to consume the nutritional supplement on a daily basis, in addition to standard nutrition. The control group will have standard nutrition provided per dietitian recommendation. Patients will have pain medication and postoperative therapies per standard of care.
The nutritional supplements will be consumed per manufacturer recommendations. Descriptions of nutritional supplementation are included below.
Juven is an oral nutritional supplement produced by Abbot Nutrition. It is not considered a drug and is not under FDA regulation. Juven has been studied in clinical trials and shown to decrease pressure ulcer occurrence, decrease muscle wasting, and increase collagen deposition in wound healing (10,11).
Juven is packaged as a powder containing 24g per pouch and is mixed with 8-10 fl oz water or juice for consumption. The recommended supplementation schedule is two servings daily in addition to balanced diet.
Nutrient data for Juven obtained from manufacturer's website 7/20/2017: https://abbottnutrition.com/juven Serving size: 24 g (1 packet) L-arginine 7g L-glutamine 7g Carbohydrate 7.9g Sugars 1g Calcium 200mg Calcium beta-hydroxy-beta-methylbutyrate 1.5g
After discharge from the hospital, we will communicate with patients by mobile phone messaging on a daily basis to confirm consumption of the investigative nutritional supplementation. We will also communicate with patients at 3 months, 6 months, 9 months, and 12 months after surgery to inquire about any complications or hospitalizations.
Following surgery, patients will be reevaluated in the orthopedic trauma clinic at routine intervals per standard of care (postoperative visits are typically scheduled at 2 weeks, 6 weeks, 6 months, and 1 year). Patients will be seen in clinic by orthopedic surgery trauma staff. All orthopedic trauma staff are included on the research team. As part of routine clinical follow up visit, research team will review the patient medical record, perform a focused history and physical exam and document any new hospital readmission, medical complication, surgical complication. Radiographs will be obtained per standard orthopedic care to assess fracture healing and no additional radiographs will be obtained for the purpose of this study.
At the patient's first postoperative clinic follow up, we will repeat measures of patient weight, body composition, and hand grip strength. These measures are expected to take less than 15 minutes at the time of their clinic appointment.
Subjects will also be asked to complete several questionnaires via RedCap at several times points during the study. The questionnaires will be completed either in clinic on a tablet or computer, or a secure link to the study will be emailed to subjects.
No data collection is planned after one year from the time of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplement group | Experimental | Dietary Supplement: JuvenSubjects 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 intervention | –Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of acute fracture of the upper extremity, pelvis, or lower extremity with plans for operative fixation
Key exclusion criteria (6 listed)
- Patients with comorbidities excluding the use of proposed nutritional supplement (phenylketonuria, galactoseria)
- Patients with major head trauma
- Pregnant women
- Dementia
- Vulnerable populations (minors, prisoners)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JuvenNutritional supplement (Juven) will be consumed daily per manufacturer recommendations | Dietary supplement | Nutritional supplement group |
Primary outcome
Change in body composition
Time frame: One year
Change in muscle mass
2 secondary outcomes
Change in hand grip strength
Time frame: One year
Number of participants with post-operative complications
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Hendrickson, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juven in people with Trauma and Nutritional Deficiency, run by Michael C Willey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.