Clinical Trial: Refeeding Syndrome in Anorexia Nervosa

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multi Site Randomized Controlled Trial on Refeeding Syndrome in Anorexia Nervosa

Brief Summary: The purpose of this multi-center randomized controlled trial is to compare lower calorie refeeding to higher calorie refeeding for hospitalized adolescents and young adults with AN. The investigators will compare efficacy (achievement and maintenance of clinical remission at 12 months), safety during hospitalization, and cost effectiveness (including costs of initial and re hospitalization, 12 month follow up and safety/adverse events).

Detailed Summary:

Anorexia nervosa (AN) is an illness commonly diagnosed in adolescence with low recovery rates and high healthcare costs. The major medical complication of AN is malnutrition. Caloric restriction, purging and other weight control behaviors can lead to medical instability (abnormal vital signs) requiring hospitalization. The primary goal of hospitalization is to restore medical stability by reintroducing nutrition, or "refeeding". Within 12 mo of discharge, 43% of patients will require medical rehospitalization. This results in a costly course of recovery, given that eating disorders are the most expensive among primary mental health diagnoses requiring hospitalization. Several lines of inquiry seeking to identify characteristics or short-term outcomes that may predict better recovery in AN point to rapid short-term weight gain as a strong predictor of long-term outcomes. Greater weight gain in hospital predicts weight recovery at 12 moand, in psychotherapeutic trials, greater weight gain during the first 3-4 wk (1.7-1.9 lb/wk) predicts full remission at 12 mo. Unfortunately, the currently recommended approach, Lower Calorie Refeeding (LCR), is associated with slow weight gain and prolonged hospital stay. Treatment is now moving sporadically toward Higher Calorie Refeeding (HCR) in the hope of improved recovery. However, no study to date has directly compared these two approaches.] Since the refeeding syndrome, characterized by rapid electrolyte shifts, delirium and cardiac arrest in response to the influx of nutrients was first described around WWII, refeeding has been approached with caution. Following documentation of this syndrome in patients with AN, conservative, consensus-based recommendations for LCR were developed to ensure safety. LCR typically begins around 1200 kilocalories (kcal) per day and advances by 200 kcal every other day. The investigators found that patients initially lose weight on this &quo
Sponsor: Stanford University

Current Primary Outcome:

• Clinical remission defined by weight and medical stability [ Time Frame: 12 months ]
  (i) weight ≥ 95% median BMI (MBMI) for age and sex, and (ii) medical stability during 12 mo follow-up defined by published vital sign thresholds. If both of these conditions are met we will consider the patient in clinical remission.
• Incidence of electrolyte inbalances [ Time Frame: 12 months ]
  We will monitor any differences in LCR and HCR by incidence of: 1- hypophosphatemia (≤3 mg/dL), 2- hypomagnesaemia (≤1.7 mg/dL), and 3- hypokalemia (≤3.5 mEq/L). If any of these three conditions occur we will record this as an instance of electrolyte inbalance.
• Cost of initial and re-hospitalizations [ Time Frame: 12 months ]
  Hospital costs, taking into account number of days in hospital and any extra services performed (blood draws, PICU consults, etc), and any rehospitalization costs.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Clinical remission defined by psychological recovery [ Time Frame: 12 months ]
  Eating Disorder Examination (EDE) global score within 1 SD of clinical norm
• Cost of 12 mo follow-up and other care [ Time Frame: 12 months ]
  Cost of outpatient visits - including medical, nutrition, and psychological

Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: November 17, 2015
Date Started: December 2015
Date Completion:
Last Updated: October 13, 2016
Last Verified: October 2016