Citrate Dialysate in Online Hemodialfiltration

February 3, 2023 updated by: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10300
        • Faculty of Medicine ,Vajira Hospital
      • Bangkok, Thailand, 10300
        • Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pre-dilution online hemodiafiltration
The study was conducted for a 28-week period in two phases: For the first 12 weeks, all of the patients were subjected to CD with pre-dilution oL-HDF.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. The second phase will run after finishing the first phase with the same protocol but with post-dilution online HDF.There will be 2 weeks washout period before starting this phase
Procedure: Pre-dilution online hemodiafiltration with citrate dialysate
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
Procedure: Post-dilution hemodiafiltration with citrate dialysate
same protocol with post-dilution Ol-HDF in these same patients for the later 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 weeks
adequacy of dialysis between pre and post dilution online-hemodiafiltration
Time Frame: 28 weeks
Kt/V
28 weeks
calcium level between pre and post dilution online-hemodiafiltration
Time Frame: 28 weeks
serum calcium predialysis in midweek of each phase
28 weeks
phosphorus level between pre and post dilution online-hemodiafiltration
Time Frame: 28 weeks
serum calcium predialysis in midweek of each phase
28 weeks
intact parathyroid level between pre and post dilution online-hemodiafiltration
Time Frame: 28 weeks
serum parathyroid level in midweek of each phase
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2022

Primary Completion (ACTUAL)

September 30, 2022

Study Completion (ACTUAL)

September 30, 2022

Study Registration Dates

First Submitted

March 6, 2022

First Submitted That Met QC Criteria

March 6, 2022

First Posted (ACTUAL)

March 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080/64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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