Medium Cut-off Dialyzers in a Large Population of Hemodialysis Patients in Colombia: COREXH Registry.

BACKGROUND AND OBJECTIVES: Expanded hemodialysis therapy (HDx) provides increased clearance of conventional and large middle molecules through innovative medium cut-off (MCO) membranes. However, there is a paucity of real-world data regarding the benefits and safety of HDx. This large observational study evaluated outcomes among patients in Colombia undergoing HDx at a large dialysis clinical services provider. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This was a prospective single cohort study of prevalent patients who were treated with HDx; baseline information was collected from the most recent data before patients were started on HDx. Patients were followed prospectively for 1 year for changes in serum albumin and other laboratory parameters compared with the baseline. Survival, hospitalization and safety were assessed from the start of HDx. RESULTS: A total of 1000 patients were invited to enroll; 992 patients met the inclusion criteria for data analysis and 638 patients completed the year of follow-up. Seventy-four (8%) patients died during 866 patient-years (PY) of follow-up; the mortality rate was 8.54 deaths/100 PY (95% confidence interval [CI], 6.8 to 10.7). There were 673 hospitalization events with a rate of 0.79 events/PY (95% CI, 0.73 to 0.85) with 6.91 hospital days/PY (95% CI, 6.74 to 7.09). The observed variability from baseline and maximum average change in mean serum albumin levels were - 1,8% and - 3,5% respectively. No adverse events were related to the MCO membrane. CONCLUSION: HDx using an MCO membrane maintains stable serum albumin levels and is safe in terms of nonoccurrence of dialyzer related adverse events. This article is protected by copyright. All rights reserved.