Comparison of Molecule Clearance and Pro-inflammatory Markers between High-Flux and Medium Cut-Off Dialyzers (ELISIO™ 21): A Cross-Over Study

Description

This dataset corresponds to a single-center, prospective, crossover study evaluating the efficacy and safety of the ELISIO™ HX dialyzer compared to the NS21 high-flux dialyzer. The study focuses on molecular clearance and inflammation markers in hemodialysis patients. Date of Dataset Creation: June 2023 - May 2024 File Information • File Name: 2024_Molecule_Clearance_ELISIO_Database • File Format: SPSS (.sav) Study Design Summary • Study Type: Prospective, crossover trial • Location: Single-center • Sample Size: 12 hemodialysis patients • Interventions: o Dialyzer A: NS21 (standard high-flux) o Dialyzer B: ELISIO™ HX (medium cut-off, MCO) • Study Duration: 4 weeks • Sequence: Randomized crossover design (two periods) • Primary Outcomes: Molecular clearance (urea, creatinine, beta-2 microglobulin) and inflammatory markers (IL-6, CRP) • Statistical Test: Paired Student's t-test (non-inferiority margin 10%) Variable Descriptions • Sexo: Patient sex (Male/Female) • Edad: Patient age (years) • HTA: History of arterial hypertension (Yes/No) • DM: History of diabetes mellitus (Yes/No) • AccesoVascular: Type of vascular access (e.g., AV fistula, catheter) • TipoHD: Type of hemodialysis (e.g., on-line HDF, conventional HD) • TiempoX: Dialysis duration (minutes) for period X • KtvX: Dialysis adequacy (Kt/V) for period X • FlujoX: Blood flow rate (mL/min) for period X • MonitorX: Dialysis monitor model used for period X • DializadorX: Dialyzer model used (NS21 or ELISIO™ HX) for period X • EventosX: Adverse events during period X (Yes/No) • UreaX.pre / UreaX.post: Pre- and post-dialysis urea (mg/dL) for period X • CreatininaX.pre / CreatininaX.post: Pre- and post-dialysis creatinine (mg/dL) for period X • AlbúminaX.pre / AlbúminaX.post: Pre- and post-dialysis albumin (g/dL) for period X • CKX.pre / CKX.post: Pre- and post-dialysis creatine kinase (U/L) for period X • FósforoX.pre / FósforoX.post: Pre- and post-dialysis phosphorus (mg/dL) for period X • PTHiX.pre / PTHiX.post: Pre- and post-dialysis intact parathyroid hormone (pg/mL) for period X • PCRX.pre / PCRX.post: Pre- and post-dialysis C-reactive protein (mg/L) for period X • ProcalcitoninaX.pre / ProcalcitoninaX.post: Pre- and post-dialysis procalcitonin (ng/mL) for period X • IL6.X.pre / IL6.X.post: Pre- and post-dialysis interleukin-6 (pg/mL) for period X • B2MicroglobulinaX.pre / B2MicroglobulinaX.post: Pre- and post-dialysis beta-2 microglobulin (mg/L) for period X • FerritinaX: Ferritin level (ng/mL) for period X • HemoglobinaX: Hemoglobin level (g/dL) for period X Note: Variables with suffixes ".pre" and ".post" represent pre- and post-dialysis measurements, respectively. “X” denotes the dialysis period (1 to 4).

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