Improving Preoperative Screening and Postoperative Nutrition in Orthopedic Sarcoma and Spine Patients: Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Injuries
- Sponsor
- University of Iowa
- Locations
- 1
- Primary Endpoint
- Body composition
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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,
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older
- •Indicated for spinal or orthopedic oncology surgery
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Body composition
Time Frame: One year
Change in muscle mass
Secondary Outcomes
- Hand grip strength(One year)
- Post-operative complications(One year)