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

Primary Purpose

Hemodialysis, Citrate, Heparin

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Citrate dialysate
Sponsored by
Bangkok Metropolitan Administration Medical College and Vajira Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Citrate arm

Arm Description

Citrate dialysate Phase 1 : Reduce heparin to 50% Phase 2: Reduce heparin to 25% Phase 3: Heparin free

Outcomes

Primary Outcome Measures

Effect of citrate dialysate to anemia
Hemoglobin in gram per dL

Secondary Outcome Measures

Effect of citrate dialysate to dialyzer clotting
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
effect of citrate dialysate to electrolyte changes
electrolyte in mmoll/L(Sodium,Potassium,Chloride and bicarbonate)
effect of citrate dialysate to dialysis adequacy
Kt/V

Full Information

First Posted
March 7, 2018
Last Updated
March 19, 2018
Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03470727
Brief Title
The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients
Official Title
The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Citrate, Heparin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective comparison study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citrate arm
Arm Type
Experimental
Arm Description
Citrate dialysate Phase 1 : Reduce heparin to 50% Phase 2: Reduce heparin to 25% Phase 3: Heparin free
Intervention Type
Device
Intervention Name(s)
Citrate dialysate
Intervention Description
Change form acetate to citrate dialysate
Primary Outcome Measure Information:
Title
Effect of citrate dialysate to anemia
Description
Hemoglobin in gram per dL
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effect of citrate dialysate to dialyzer clotting
Description
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
Time Frame
3 months
Title
effect of citrate dialysate to electrolyte changes
Description
electrolyte in mmoll/L(Sodium,Potassium,Chloride and bicarbonate)
Time Frame
3 months
Title
effect of citrate dialysate to dialysis adequacy
Description
Kt/V
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thananda Trakarnvanich, MD
Organizational Affiliation
Faculty of Medicine,Vajira Hospital,Navamindradhiraj University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine ,Vajira hospital,Navamindradhiraj University
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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