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Abstract: FR-OR55

Oral Intradialytic Nutritional Supplements and Mortality in Hemodialysis Patients: A Cluster-Randomized, Pragmatic Clinical Trial

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Weiner, Daniel E., Tufts Medical Center, Boston, Massachusetts, United States
  • Majchrzak, Karen M., Dialysis Clinic Inc, Nashville, Tennessee, United States
  • Kinnard, Cindy D, Dialysis Clinic Inc, Nashville, Tennessee, United States
  • Tighiouart, Hocine, Tufts Medical Center, Boston, Massachusetts, United States
  • Marren, Todd, Dialysis Clinic Inc, Nashville, Tennessee, United States
  • Lacson, Eduardo K., Dialysis Clinic Inc, Nashville, Tennessee, United States
  • Johnson, Doug, Dialysis Clinic Inc, Nashville, Tennessee, United States

Group or Team Name

  • on behalf of Dialysis Clinic, Inc
Background

Dialysis is a catabolic state and observational studies suggest that administering oral nutritional supplements to hemodialysis patients with low serum albumin during the dialysis session may reduce mortality. Whether there are benefits in patients with normal serum albumin remains unstudied.

Methods

The Health Effects of oraL Protein Supplements in HD (HELPS-HD) Trial was an open-label cluster randomized pragmatic trial, comparing the effects of an intensive oral nutritional supplement protocol in which prevalent hemodialysis patients received supplements at every dialysis session regardless of serum albumin to standard care, in which supplements were administered to patients with albumin below 3.5 g/dL. As part of standard care, all incident patients received supplements for the first 90 days of dialysis. Following randomization of facilities to either the intensive or standard protocol, patients in facilities provided informed consent via waiver of consent documentation. The study intervention lasted from January 2017 to March 2020, and patients were enrolled through December 2019. The primary outcome, all-cause mortality, was assessed from medical records.

Results

Among 10,043 hemodialysis patients randomized from 105 participating DCI facilities, mean age was 63 years, 56% were men, 36% Black, and 46% had diabetes as primary cause of kidney failure; 32% were incident to dialysis. Supplement use was 2-fold higher in the 53 clinics randomized to the intensive protocol. Over median follow-up of 21 months, there were 3628 deaths, 35.8% in the intensive and 36.5% in the standard group, with an unadjusted rate of 20 deaths per 100-person years in both groups. In unadjusted Cox models, those randomized to the intensive protocol had similar outcomes to those randomized to the standard protocol (HR 1.02 [0.92, 1.14]); results were similar in models adjusted for age, sex and race and between incident and prevalent patients.

Conclusion

Discussion
In a large, national population of hemodialysis patients, there was no difference in mortality between patients randomized to a standard oral nutritional supplement protocol, with receipt of supplements only when serum albumin was low, as compared to an intensive protocol, with receipt of supplements regardless of serum albumin.

Funding

  • Commercial Support