Spine and Tumor Screening and Supplementation
- Conditions
- Nutritional DeficiencySpinal InjuriesSarcoma
- Interventions
- Dietary Supplement: Juven
- Registration Number
- NCT03660540
- Lead Sponsor
- University of Iowa
- Brief Summary
This project aims to evaluate an implementable screening tool and nutritional interventions that will lead to improved quality and patient safety. The aims of this pilot study are twofold:
Purpose 1: assess the prognostic value of malnutrition and sarcopenia for identifying patients at increased risk of adverse postoperative outcomes following elective or semi-elective orthopedic procedures.
Purpose 2: assess the clinical benefit of postoperative oral supplementation with a commercially-available nutritional supplement that includes conditionally-essential branched chain amino acids.
- Detailed Description
All patients will be treated according to standard of care for their orthopedic injuries, including standard nutritional support in the preoperative period. Patients admitted to our academic Level I trauma center with spinal fractures and sarcoma requiring limb reconstruction will be approached for consent to participate in this study. Consented patients will be prospectively enrolled at the time of admission. We will obtain relevant patient medical history, standard preoperative labs, radiographic imaging, and nutritional assessment at the time of admission. Patients will be assessed for the presence of sarcopenia utilizing ultrasound measures of skeletal muscle as previously described.
All patients will be evaluated by a clinical dietitian or dietetic assistant for nutritional assessment as part of the standard of care. In addition to screening for sarcopenia and malnutrition, we will assess the clinical benefit of oral nutritional supplementation with essential branched-chain amino acids in a population of trauma patients. Patients providing written informed consent will be enrolled in a prospective RCT to assess nutritional supplementation with conditionally essential branched-chain amino acids. Patients will be randomly assigned to receive standard nutritional support or standard nutrition plus oral supplementation with a commercially available nutritional supplement containing essential branched chain amino acids (Juven, Abbot Nutrition). Similar combinations of essential amino acids have previously demonstrated protective effects against skeletal muscle wasting and medical complications in immobilized critically ill patients. Patients will be prospectively followed for 12 months from the time of admission to assess clinical outcomes. Our primary outcome measures include skeletal muscle mass changes, wound healing complications,
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 18 years of age or older
- Indicated for spinal or orthopedic oncology surgery
- Unable to provide written consent
- Unable to comply with postoperative treatment recommendations
- Do not plan to follow up at the facility where surgery occurred
- Food allergy to ingredients in dietary supplement
- Intolerance to oral diet including phenylketonuria
- Pregnant women
- Individuals with dementia
- Vulnerable populations (minors, prisoners)
- Individuals lacking decision making capacity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutritional supplement group Juven 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.
- Primary Outcome Measures
Name Time Method Body composition One year Change in muscle mass
- Secondary Outcome Measures
Name Time Method Hand grip strength One year Change in hand grip strength as measured by hand held dynamometer
Post-operative complications One year Medical and surgical complications following operative fracture fixation, validated patient
Trial Locations
- Locations (1)
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States