Pre-Operative nutrition In Neck of femur Trial (POINT)--carbohydrate loading in patients with fragility hip fracture: study protocol for a randomised controlled trial

• Published in: Trials Vol. 15; no. 1; p. 475
• Main Authors: Moppett, Iain K, Greenhaff, Paul L, Ollivere, Ben J, Joachim, Theophillus, Lobo, Dileep N, Rowlands, Martin
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 04.12.2014; BioMed Central
• Subjects: Administration, Oral; Age Factors; Aged; Beverages; Biopsy; Blood sugar monitoring; Care and treatment; Clinical Protocols; Diet therapy; Dietary Carbohydrates - administration & dosage; Dietary Carbohydrates - adverse effects; Dietary Carbohydrates - metabolism; England; Femoral Neck Fractures - diagnosis; Femoral Neck Fractures - metabolism; Femoral Neck Fractures - physiopathology; Femoral Neck Fractures - surgery; Fractures; Frail Elderly; Geriatric Assessment; Health aspects; Hemiarthroplasty; Humans; Insulin Resistance; Methods; Muscle, Skeletal - metabolism; Nutrition Assessment; Nutritional Status; Physiological aspects; Pilot Projects; Preoperative Care; Prospective Studies; Research Design; Sample Size; Study Protocol; Time Factors; Treatment Outcome; England; United Kingdom
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/1745-6215-15-475

Trauma such as hip fracture initiates a neurohumoral stress response that changes the balance between anabolism and catabolism resulting in muscle breakdown and reduced mobilisation. Various studies have demonstrated a reduction in catabolism with pre-operative carbohydrate loading but only in an elective setting. This is a two-centre, randomised double-blinded trial in the United Kingdom. Sample size will be 30 patients (approximately 15 from each centre). Randomisation will be web based using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be >70 years of age, cognitively intact (Abbreviated Mental Score ≥ 7), able to give informed consent, and admitted directly through the emergency department with fractured neck of femur requiring hemiarthroplasty. Intervention will consist of two carbohydrate drinks (Nutricia pre-Op) given the night before, and the morning of the surgery. The control will receive two placebo drinks of equal volume. All participants will receive standard hospital care at the discretion of the clinical team. The primary outcome is the difference between groups in insulin resistance calculated by a glucose tolerance test administered pre-operatively and 24 hours postoperatively. Secondary endpoints will be changes in muscle carbohydrate metabolism (biopsy), mobility (Cumulative Ambulation Score) and subjective measures of tolerability. This is a small-scale pilot study, investigating the benefits and tolerability of carbohydrate loading in an emergency setting in a frail elderly group with known high morbidity and mortality. Positive findings will provide the basis for a larger scale study. Current Controlled Trials ISRCTN91109766 (7 April 2014); NRES ref: 13/EM/0214Trial Sponsor: University of Nottingham Ref.13036.