Monitored Intradialytic Oral Nutritional Supplements and Hospitalization Risk in Chronic Hemodialysis

We report the hospitalization risk among participants and non-participants in a Fresenius Medical Care North America program offering monitored intradialytic oral nutritional supplements (ONS) for chronic hemodialysis patients with low serum albumin. All ONS program-eligible patients with albumin <= 3.5 g/dL in Q4-2009 without ONS in the prior 90-days and did not receive any ONS external to the program were eligible. Participants initiated ONS within Q4-2009 while controls did not receive ONS at anytime during the follow-up period. In addition to the full study cohort, a 1: 1 geographic region and propensity score matched study population (utilizing case-mix, labs, access type, 30-day prior hospitalization, incident patient status) was followed for hospitalization until 12/31/2010. The sensitivity analysis restricted eligible control patients to 30+ day survivors after qualifying for participation, providing sufficient "lag" period for the opportunity to be offered ONS. Hospitalization was less in the ONS cohort at 2.5 vs. 2.7 episodes/patient-year and corresponding 19.2 vs. 20.4 hospital days/patient-year (both p<0.001) as well as a lower observed death rate of 29.4% vs. 36.6%. Hazard ratios for 1st hospitalization with ONS were 0.93 (0.90, 0.96) for the entire cohort, 0.97 (0.92, 1.02) in the matched cohort, and 0.90 (0.86, 0.95) in the matched "lag" cohort - all adjusted for case-mix, prior hospitalization within 30 days of study entry, SMR and laboratory results. Chronic hemodialysis patients with albumin <= 3.5 g/dL who received monitored intradialytic ONS exhibited significantly lower hospitalization risk than similar, matched patient controls. These results require confirmation in prospective clinical trials.