Skip to main content
OpenTrials
Completed

NCT Number: NCT05280106

Citrate Dialysate in Online Hemodialfiltration

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemodiafiltration Citrate Reaction Haemodialysis Heparin

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine ,Vajira Hospital, Bangkok, Thailand

Loading trial locations.

About this study

Heparin is the most routinely used anticoagulant in hemodialysis. However, it exposes the patient to the risk of bleeding complications and can induce thrombocytopenia. Furthermore, long-term use of heparin induces biological and clinical complications (osteoporosis, dyslipidemia, hyperkalemia) . Regional citrate anticoagulation is a good alternative to heparin use in hemodialysis for patients with increased bleeding risk , but its implementation in bicarbonate hemodialysis (BHD) is laborious and cumbersome: severe side effects can occur due to citrate metabolism and difficulties in adaptation of calcium infusion into the venous line .Therefore, the use of citrate as a dialysis buffer instead of acetate has proven a safe alternative to acetate-containing bicarbonate dialysis and on-line hemodiafiltration without significant hypocalcemia or clinically important coagulation issues.The aim of the present study is the comparison of the patency of the dialyzer ,the quality of life and blood parameters between pre and potdiltuiotn Ol-HDF with citrate dialysate (CD). No study to date has previously compared the use of citrate dialysate between these two modalities in oL-HDF.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable condition
  • Having been under HD for at least three months
  • he vascular access should have blood flow ≥ 300 mL/min.

Exclusion criteria

  • no heparin use during HD
  • refusal to participate,
  • intolerance or allergy to citrate
  • concurrent infection
  • poor life expectancy due to metastatic cancer, severe cirrhosis and AIDS.
  • patients vascular access modification,
  • patients affected by chronic liver disease, active neoplastic or inflammatory disease were excluded as well as patients receiving immunosuppressive or anti-inflammatory drugs.

Treatment and study plan

Pre-dilution online hemodiafiltration with citrate dialysate

Procedure

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 dialysate

Procedure

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

Primary outcomes

  1. clotting score between pre and post dilution online-hemodiafiltration

    Time frame: 28 weeks

    5 grades of clotting score, Grade 1;No or very little residual blood in the filters.Grade 1;Residual blood in less than 10% of the fibers. Grade 2; Residual blood 10-25%. Grade 3; Residual blood 25-50%.Grade 4 ,Residual blood > 50%

Secondary outcomes

  1. quality of life between pre and post dilution online-hemodiafiltration

    Time frame: 28 weeks

    KDQOL-sf score;0-100.Higher scores reflect better quality of life

  2. adequacy of dialysis between pre and post dilution online-hemodiafiltration

    Time frame: 28 weeks

    Kt/V

  3. calcium level between pre and post dilution online-hemodiafiltration

    Time frame: 28 weeks

    serum calcium predialysis in midweek of each phase

  4. phosphorus level between pre and post dilution online-hemodiafiltration

    Time frame: 28 weeks

    serum calcium predialysis in midweek of each phase

  5. intact parathyroid level between pre and post dilution online-hemodiafiltration

    Time frame: 28 weeks

    serum parathyroid level in midweek of each phase

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.