Refeeding risks in patients requiring intravenous nutrition support: Results of a two-centre, prospective, double-blind, randomised controlled trial.

Summary Background/aims Refeeding syndrome can result following excessive feeding of malnourished patients. The syndrome remains poorly defined but encompasses a range of adverse effects including electrolyte shifts, hyperglycaemia and other less well-defined phenomena. There are additional risks of underfeeding malnourished individuals. Studies of refeeding syndrome have generally focussed on critical care environments or patients with anorexia nervosa. Here we have conducted a two-centre, prospective, double-blind, randomised controlled trial amongst all patients referred to hospital nutrition support teams for intravenous nutrition support. We sought to determine whether electrolyte and other abnormalities suggestive of refeeding syndrome risk varied depending on initial rate of intravenous feeding. Methods Patients at moderate or high risk of refeeding syndrome, as defined by United Kingdom National Institute of Health and Care Excellence guidelines, were screened for inclusion. Patients were randomised to receive either high (30 kcal/kg/day, 0.25 gN/kg/day) or low (15 kcal/day, 0.125 gN/kg/day) rate feeding for the first 48 h prior to escalation to standard parenteral nutrition regimens. The primary outcome was rates of potential refeeding risks within the first 7 days as defined by electrolyte imbalance or hyperglycaemia requiring insulin. Secondary outcomes included effects on QTc interval, infections and length of hospital stay. Statistical analysis was performed with χ2 or Wilcoxon rank sum tests and all analysis was intention-to-treat. Problems with study recruitment led to premature termination of the trial. Registered on the EU Clinical Trials Register (EudraCT number 2007-005547-17). Results 534 patients were screened and 104 randomised to either high or low rate feeding based on risk of refeeding syndrome. Seven patients were withdrawn prior to collection of baseline demographics and were excluded from analysis. 48 patients were analysed for the primary outcome with potential refeeding risks identified in 46%. No differences in risks were seen between high and low rate feeding (p > 0.99) or high and moderate risk feeding (p = 0.68). There were no differences in QTc abnormalities, infection rates, or hospital length of stay between groups. Conclusions In this randomised trial of rates of refeeding risk, in patients pre-stratified as being at high or moderate risk, we found no evidence of increased refeeding related disturbances in those commenced on high rate feeding compared to low rate. No differences were seen in secondary endpoints including cardiac rhythm analysis, infections or length of stay. Our study reflects real world experience of patients referred for nutrition support and highlights challenges encountered when conducting clinical nutrition research.