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.


METHODS
Retrospective matched-cohort study.


METHODS
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.


METHODS
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.


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


METHODS
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.


CONCLUSIONS
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.
Fresenius Medical Care, North America, Waltham, MA, USA. elacsonj@fmc-na.com
Eduardo
E
Lacson
Weiling
W
Wang
Barbara
B
Zebrowski
Rebecca
R
Wingard
Raymond M
RM
Hakim
D000368:Aged; D000369:Aged, 80 and over; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D034141:Hypoalbuminemia / Q000209:etiology / Q000401:mortality*; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D058996:Quality Improvement; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000628:therapy; D012189:Retrospective Studies; D012709:Serum Albumin / Q000032:analysis; D016896:Treatment Outcome
D012709:Serum Albumin