Skip to main content
OpenTrials
Completed

NCT Number: NCT03470727

The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients

Acetate-free citrate containing dialysate is expected to be clinically effective in maintaining hemodynamic stability during hemodialysis (HD). It has been demonstrated that citrate dialysate help produce a local anticoagulant effect by chelating ionized calcium. Moreover, citrate can improve phosphate and beta2 macroglobulin and better control of arterial hypertension and hemoglobinemia. We therefore would like to study the effect of citrate dialysate on clot formation and anemia while reducing heparin in chronic hemodialysis patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemodialysis Citrate Heparin

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Bangkok, 10300, Thailand

About this study

This is the prospective comparison study. This study enrolled chronic hemodialysis patients age more than 18 who undergo hemodialysis 3 times per week for at least 3 months. All the patients should have serum ferritin 200-1000 ng/L and TSAT of 15-50%. The investigators exclude patients with age more than 70 years, comorbidities influencing citrate metabolism (hepatic failure,liver transplantation,cancer with bone metastasis), patients using heparin free protocol, hyperkalemia worsened by hypocalcemia, contraindication to heparin, treatment with cinacalcet or oral anticoagulant, patients using central venous catheter with blood flow less than 300 ml/min, and patients using low molecular weight heparin.

The study will be conducted in three phases over a period of 4 months. After run-in period for 2 weeks using acetate dialysate, the heparin dose will be titrated to lowest effective dose. During the first phase, citrate was replaced for acetate and heparin will be reduced to 50%. The second and third phase will be performed by reducing heparin doses to 25 % and heparin free consecutively. Each phase lasts for 4 weeks. Washout period for 2 weeks will be alternated after each phase.

Data collection: The investigators measure blood chemistries such as CBC, BUN creatinine electrolytes calcium phosphorus and KT/V at the beginning and at the end of each session. Ionized calcium will be monitored pre and post dialysis in each session. In addition, the investigators record clot score and erythropoietin dosage in each session and each phase.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • This study enrolled chronic hemodialysis patients age more than 18 who undergo hemodialysis 3 times per week for at least 3 months.
  • Serum ferritin 200-1000 ng/L and TSAT of 15-50%.

Exclusion criteria

  • age more than 70 years,
  • comorbidities influencing citrate metabolism (hepatic failure,liver transplantation,cancer with bone metastasis),
  • patients using heparin free protocol,hyperkalemia worsened by hypocalcemia
  • contraindication to heparin,
  • treatment with cinacalcet, or oral anticoagulant
  • patients using central venous catheter with blood flow less than 300 ml/min
  • patients using low molecular weight heparin

Treatment and study plan

Citrate Dialysate

Device

Change form acetate to citrate dialysate

Primary outcomes

  1. Effect of citrate dialysate to anemia

    Time frame: 3 months

    Hemoglobin in gram per dL

Secondary outcomes

  1. Effect of citrate dialysate to dialyzer clotting

    Time frame: 3 months

    clot score.The clot score ranges from 1-4.Score 1 means no residual blood or less than 10 % in the fibers Score 2 means residual blood in < 10-25% of the fiber score 3 means residual blood in 25-50 % of the fiber Score 4 means more than 50 % of the fiber Score3

  2. effect of citrate dialysate to electrolyte changes

    Time frame: 3 months

    electrolyte in mmoll/L(Sodium,Potassium,Chloride and bicarbonate)

  3. effect of citrate dialysate to dialysis adequacy

    Time frame: 3 months

    Kt/V

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2018
Registry last updated
Mar 20, 2018

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.