Similar mortality seen with intensive oral nutritional supplement vs standard protocol
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Patients who receive an intensive oral nutritional supplement protocol showed no difference in mortality outcomes compared with patients who received a standard oral nutritional protocol, according to results presented at ASN Kidney Week.
“It is important to say that this doesn’t tells us anything about giving protein supplements to people with low serum albumin ... We have reasonable observation data that suggests it is a good thing. We have good basic science data that shows that hemodialysis is a catabolic procedure and that oral nutritional supplements can abrogate that catabolism. This does not speak to people with low serum albumin. It only speaks to be with more normal serum albumin levels,” Daniel E. Weiner, MD, MS, FASN, said.
Weiner and colleagues conducted the Health Effects of Oral Protein Supplements in HD (HELPS-HD) trial, which is an open-label, cluster-randomized, pragmatic clinical trial of the effects of oral intradialytic nutritional supplements.
“This clustered, randomized pragmatic clinical trial looks at a real-world question that we are facing in dialysis patients. Do nutritional supplements help? In particular, do they help in people with reasonable intact nutritional status measured, albeit imperfectly, with serum albumin levels?”
Among patients on hemodialysis, the researchers compared the intensive oral nutritional supplement protocol for patients receiving supplements at every dialysis session regardless of serum albumin to the standard protocol in which only patients with albumin less than 3.5 g/dL received supplements.
The study enrolled 10,457 patients from 105 participating DCI facilities, of which 414 were excluded from primary analysis. Mean patient age was 63 years. Overall, 36% of patients were Black, 56% were men and 46% had diabetes as the primary cause of kidney failure. Additionally, 33% of patients were incident to dialysis. All incident patients received supplements for the first 120 days of dialysis.
Patients were randomized to either the intensive protocol group or the standard protocol group. Supplement use was twofold higher in 53 clinics randomized to the intensive protocol. Intervention was from January 2017 to March 2020, which ended early because of the COVID-19 pandemic. The primary outcome of all-cause mortality was assessed from medical records. Mean follow-up was 21.2 months. Standard nutritional supplements were used with half of the facilities using protein bars. The criteria were 15 g to 20 g of protein for the supplements.
“We tried to keep this as real-world and pragmatic as possible,” Weiner said.
Weiner and colleagues reported 3,628 deaths (35.8% in the intensive group and 36.5% in the standard group). He said the unadjusted rate was 20 deaths per 100-person years in both groups. In unadjusted Cox models, patients in the intensive protocol group had similar outcomes to patients in the standard protocol group. Results were similar when adjusted for age, sex and race, as well as incident and prevalent patients.
Weiner said the trial just ended and further data cleaning remains, which includes hospitalization outcomes.
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Weiner DE, et al. Paper FR-OR55. Presented at: ASN Kidney Week. Oct. 22-25, 2020 (virtual meeting).
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