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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03470727
Other study ID # 71/2560
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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