Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03658278 |
| Other study ID # |
201706789 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2018 |
| Est. completion date |
November 13, 2019 |
Study information
| Verified date |
September 2023 |
| Source |
University of Iowa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
1. Age
2. Sex
3. Height
4. Weight
5. BMI
6. 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
7. MSSA (methicillin-susceptible Staphylococcus aureus) /MRSA (methicillin-resistant
Staphylococcus aureus) nasal colonization status (standard preoperative evaluation)
8. tobacco use history
9. history of DVT (deep vein thrombosis) or PE (pulmonary embolism)
10. 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.
