title: Pre-Operative nutrition In Neck of femur Trial (POINT)--carbohydrate loading in patients with fragility hip fracture: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN91109766 (7 April 2014); NRES ref: 13/EM/0214Trial Sponsor: University of Nottingham Ref.13036.
authors.affiliation: Associate Professor and Honorary Consultant Anaesthetist, Anaesthesia and Critical Care Research Group, Division of Clinical Neuroscience, University of Nottingham, Nottingham NG7 2UH, UK. Iain.Moppett@nottingham.ac.uk.
authors.forename: Iain K
authors.initials: IK
authors.lastname: Moppett
authors.forename: Paul L
authors.initials: PL
authors.lastname: Greenhaff
authors.forename: Ben J
authors.initials: BJ
authors.lastname: Ollivere
authors.forename: Theophillus
authors.initials: T
authors.lastname: Joachim
authors.forename: Dileep N
authors.initials: DN
authors.lastname: Lobo
authors.forename: Martin
authors.initials: M
authors.lastname: Rowlands
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D001628:Beverages; D001706:Biopsy; D002985:Clinical Protocols; D004040:Dietary Carbohydrates / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism; D004739:England; D005265:Femoral Neck Fractures / Q000175:diagnosis / Q000378:metabolism / Q000503:physiopathology / Q000601:surgery*; D016330:Frail Elderly; D015577:Geriatric Assessment; D062785:Hemiarthroplasty; D006801:Humans; D007333:Insulin Resistance; D018482:Muscle, Skeletal / Q000378:metabolism; D015596:Nutrition Assessment; D009752:Nutritional Status; D010865:Pilot Projects; D011300:Preoperative Care; D011446:Prospective Studies; D012107:Research Design; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004040:Dietary Carbohydrates