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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470727
• Other study ID #: 71/2560
• Status: Completed
• Phase: N/A
• First received: March 7, 2018
• Last updated: March 19, 2018
• Start date: September 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Citrate
• Hemodialysis
• Heparin

Intervention

Device:
• Citrate dialysate
Change form acetate to citrate dialysate

Locations

Country	Name	City	State
Thailand	Faculty of Medicine ,Vajira hospital,Navamindradhiraj University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of citrate dialysate to anemia	Hemoglobin in gram per dL	3 months
Secondary	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
Secondary	effect of citrate dialysate to electrolyte changes	electrolyte in mmoll/L(Sodium,Potassium,Chloride and bicarbonate)	3 months
Secondary	effect of citrate dialysate to dialysis adequacy	Kt/V	3 months