CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Pre-dilution online hemodiafiltration with citrate dialysate +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT05280106
NCT05280106N/ACompleted

Comparison of Citrate Dialysate in Predilution and Postdilution Online Hemodiafiltration : Effect on Clot Formation and Adequacy of Dialysis in Hemodialysis Patients

Bangkok Metropolitan Administration Medical College and Vajira Hospital·interventional·Posted Mar 15, 2022·Updated Feb 8, 2023

In Brief

A clinical study evaluating Pre-dilution online hemodiafiltration with citrate dialysate and Post-dilution hemodiafiltration with citrate dialysate for Hemodiafiltration and 3 related conditions. Completed, enrolled 9 participants across 2 sites.

Detailed Summary

Online hemodiafiltration (Ol-HDF) is increasingly being used for patients on chronic dialysis due to in its superiority compared with standard hemodialysis HDF. In addition to an excellent clearance of small molecules, oL-HDF has more advantages by providing both diffusion and convection modalities for an additional clearance of medium-size molecules. Furthermore, OL-HDF has been associated with not only better hemodynamic tolerance and biocompatibility , but may even include better survival.with reduction of proinflammatory cytokines and proinflammatory circulating cells , as well as with better control of B2MG levels .Ol-HDF is classified into 2 types according to the mode of addition of the substitution fluid: pre-dilution OL-HDF (pre-HDF) and post-dilution OL-HDF (post-HDF); Post-HDF was associated with significantly higher removal rates of β2-MG than HD. Postdilution HDF is the most effective way to maximize molecule clearance .Post-HDF was associated with significantly higher removal rate of α1-MG, and also significantly higher albumin leakage, than HD and pre-HDF. However, blood concentrations can be elevated using HDF, which can cause thrombosis. On the other hand, predilution HDF can resolve this problem but requires about three times more purified water than postdilution HDF and may not elicit maximal clearance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesThailand
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 15, 2022
Enrollment StartFeb 1, 2022
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.3 years ago

Interventions

Pre-dilution online hemodiafiltration with citrate dialysateprocedure

After enrollment, all patients began a 2-week run-in period with conventional dialysis fluid containing acetate and the lowest dose of unfractionated heparin. The investigator titrated the heparin dose by reducing the dose step by step, 25% in each step, until the final minimal dose was achieved. The experimental study consisted of 3 phases, 4 weeks in each phase, and the phases were separated by 1-week washout periods. Phase 1 used CD with 50% of the heparin dose of the baseline. Phases 2 and 3 used 25% heparin and no heparin, respectively. New dialyzers were introduced at the beginning of each phase and the heparin dose was resumed during the washout phase. The calcium concentration in the dialysis fluid was kept constant (1.5 mmol/L) to allow evaluation of the effect of CD on calcium balance

Post-dilution hemodiafiltration with citrate dialysateprocedure

same protocol with post-dilution Ol-HDF in these same patients for the later 12 weeks.