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American Journal of Kidney Diseases

Outcomes Associated With Intradialytic Oral Nutritional Supplements in Patients Undergoing Maintenance Hemodialysis: A Quality Improvement Report

      Background

      Insufficient clinical data exist to determine whether provision of oral nutritional supplements during dialysis can improve survival in hypoalbuminemic maintenance hemodialysis patients.

      Study Design

      Retrospective matched-cohort study.

      Setting & Participants

      All oral nutritional supplement program–eligible in-center maintenance hemodialysis patients with albumin level ≤3.5 g/dL in quarter 4 of 2009 without oral nutritional supplements in the prior 90 days at Fresenius Medical Care, North America facilities.

      Quality Improvement Plan

      Monitored intradialytic oral nutritional supplements were provided to eligible maintenance hemodialysis patients upon physician order, to continue for a year or until serum albumin level was ≥4.0 g/dL.

      Outcome

      Mortality (including deaths and withdrawals), followed up until December 31, 2010.

      Measurements

      Both an intention-to-treat (ITT) and an as-treated analysis was performed using a 1:1 geographic region and propensity score–matched study population (using case-mix, laboratory test, access type, 30-day prior hospitalization, and incident patient status) comparing patients treated with intradialytic oral nutritional supplements with usual-care patients. Cox models were constructed, unadjusted and adjusted for facility standardized mortality ratio and case-mix and laboratory variables.

      Results

      The ITT and as-treated analyses both showed lower mortality in the oral nutritional supplement group. The conservative ITT models with 5,227 matched pairs had 40% of controls subsequently receiving oral nutritional supplements after January 1, 2010 (because many physicians delayed participation), with comparative death rates of 30.1% versus 30.4%. The corresponding as-treated (excluding crossovers) death rates for 4,289 matched pairs were 30.9% versus 37.3%. The unadjusted ITT mortality HR for oral nutritional supplement use was 0.95 (95% CI, 0.88-1.01), and the adjusted HR was 0.91 (95% CI, 0.85-0.98); the corresponding as-treated HRs were 0.71 (95% CI, 0.66-0.76) and 0.66 (95% CI, 0.61-0.71) before and after adjustment, respectively.

      Limitations

      Limited capture of oral nutritional supplement intake outside the facility and potential residual confounding from unmeasured variables, such as dietary intake.

      Conclusions

      Maintenance hemodialysis patients with albumin levels ≤3.5 g/dL who received monitored intradialytic oral nutritional supplements showed survival significantly better than similar matched patient controls, with the as-treated analysis highlighting the potentially large effect of this strategy in clinical practice.

      Index Words

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      Linked Article

      • Intradialytic Oral Nutritional Supplements Improve Quality of Life
        American Journal of Kidney DiseasesVol. 61Issue 2
        • Preview
          We applaud Dr Lacson and colleagues1 on their important work demonstrating the positive impact of intradialytic oral nutritional supplementation (ONS) on hemodialysis patient survival. Years ago, we performed a study in which participants consumed an ONS product (16.6 g of protein and 475 calories per 240-mL serving) thrice weekly with each hemodialysis session.2 After 3 months, serum albumin values showed a significant benefit in study participants compared with patients in the unit who did not participate in the program.
        • Full-Text
        • PDF
      • A More Cautious Stance on Nutritional Supplementation for Hypoalbuminemia Is Justified
        American Journal of Kidney DiseasesVol. 61Issue 2
        • Preview
          The retrospective study by Lacson et al,1 which reported that intradialytic oral nutritional supplementation was associated with reduced risk of death, raises several issues that deserve comment. The study selected “malnourished” individuals who would benefit from supplementation by identifying those with low serum albumin levels. Yet as we and others recently described in great detail,2,3 in the great majority of instances serum albumin level is a very poor predictor of protein-energy malnutrition.
        • Full-Text
        • PDF