The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT03470727|
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hemodialysis Citrate Heparin||Device: Citrate dialysate||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective comparison study|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||December 30, 2017|
|Actual Study Completion Date :||December 31, 2017|
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
- Effect of citrate dialysate to anemia [ Time Frame: 3 months ]Hemoglobin in gram per dL
- 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
- effect of citrate dialysate to electrolyte changes [ Time Frame: 3 months ]electrolyte in mmoll/L(Sodium,Potassium,Chloride and bicarbonate)
- effect of citrate dialysate to dialysis adequacy [ Time Frame: 3 months ]Kt/V
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470727
|Faculty of Medicine ,Vajira hospital,Navamindradhiraj University|
|Bangkok, Thailand, 10300|
|Principal Investigator:||Thananda Trakarnvanich, MD||Faculty of Medicine,Vajira Hospital,Navamindradhiraj University|