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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Heparin; Citrate
• Intervention / Treatment: Device: Citrate dialysate

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Citrate arm; Citrate dialysate Phase 1 : Reduce heparin to 50% Phase 2: Reduce heparin to 25% Phase 3: Heparin free	Device: Citrate dialysate; Change form acetate to citrate dialysate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of citrate dialysate to anemia	Hemoglobin in gram per dL	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
effect of citrate dialysate to electrolyte changes	electrolyte in mmoll/L(Sodium,Potassium,Chloride and bicarbonate)	3 months
effect of citrate dialysate to dialysis adequacy	Kt/V	3 months

Collaborators and Investigators

• Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Investigators: Principal Investigator: Thananda Trakarnvanich, MD, Faculty of Medicine,Vajira Hospital,Navamindradhiraj University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 71/2560

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No