Dialyzer Performance During Hemodialysis Without Systemic Anticoagulation Using a Heparin-Grafted Dialyzer Combined With a Citrate-Enriched Dialysate: Results of the Randomized Crossover Noninferiority EvoCit Study
| Autor: | Wilfried Cools, Marie-Laure Cambier, Kristin Jochmans, Christelle Orlando, Karl Martin Wissing, Annelies Tonnelier, Dieter De Clerck, K. François |
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| Přispěvatelé: | Clinical sciences, Faculty of Medicine and Pharmacy, Nephrology, Supporting clinical sciences, Hematology, Basic (bio-) Medical Sciences, Clinical Biology, Reproductive immunology and implantation, Public Health Sciences, Biostatistics and medical informatics |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_treatment
Urea reduction ratio 030232 urology & nephrology Citric Acid 03 medical and health sciences 0302 clinical medicine Renal Dialysis Dialysis Solutions Clinical endpoint Medicine Humans 030212 general & internal medicine Citrates Dialysis Not evaluated Dialysis adequacy business.industry Heparin Anticoagulants Discontinuation Nephrology Anesthesia Hemodialysis business medicine.drug |
| Zdroj: | American journal of kidney diseases : the official journal of the National Kidney Foundation. 79(1) |
| ISSN: | 1523-6838 |
| Popis: | Rationale & Objective The EvoCit study was designed to evaluate performance of a heparin-grafted dialyzer during hemodialysis with and without systemic anticoagulation. Study Design Randomized, crossover, noninferiority trial. Noninferiority was defined as a difference of ≤10% for the primary outcome. Setting & Participants Single hemodialysis center; 26 prevalent patients treated with 617 hemodialysis sessions. Interventions Hemodialysis using a heparin-grafted dialyzer combined with a 1.0 mmol/L citrate-enriched dialysate (“EvoCit”) without systemic anticoagulation compared with hemodialysis performed with a heparin-grafted dialyzer with systemic heparin (“EvoHep”). Patients were randomly allocated to a first period of 4 weeks and crossed over to the alternative strategy for a second period of 4 weeks. Outcomes The primary end point was the difference in Kt/Vurea between EvoCit and EvoHep. Secondary end points were urea reduction ratio, middle molecule removal, treatment time, thrombin generation, and reduction in dialyzer blood compartment volume. Results The estimated difference in Kt/Vurea between EvoCit and EvoHep was −0.03 (95% CI, −0.06 to −0.007), establishing noninferiority with mean Kt/Vurea of 1.47 ± 0.05 (SE) for EvoCit and 1.50 ± 0.05 for EvoHep. Noninferiority was also established for reduction ratios of urea and β2-microglobulin. Premature discontinuation of dialysis was required for 4.2% of sessions among 6 patients during EvoCit and no sessions during EvoHep. Effective treatment time was 236 ± 5 minutes for EvoCit and 238 ± 1 minutes for EvoHep. Thrombin generation was increased and there was greater reduction in dialyzer blood compartment volume after treatments with EvoCit compared with EvoHep. Limitations The effects of avoiding systemic anticoagulation on clinical outcomes were not evaluated. Conclusions EvoCit is noninferior to EvoHep with respect to solute clearance but results in a greater number of shortened treatments, more membrane clotting, and greater thrombin generation Trial Registration Registered at ClinicalTrials.gov with study number NCT03887468. |
| Databáze: | OpenAIRE |
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