ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 97 for:    calcium cation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03470727
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Citrate Heparin Device: Citrate dialysate Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective comparison study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Effect of citrate dialysate to anemia [ Time Frame: 3 months ]
    Hemoglobin in gram per dL


Secondary Outcome Measures :
  1. 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

  2. effect of citrate dialysate to electrolyte changes [ Time Frame: 3 months ]
    electrolyte in mmoll/L(Sodium,Potassium,Chloride and bicarbonate)

  3. effect of citrate dialysate to dialysis adequacy [ Time Frame: 3 months ]
    Kt/V



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Thailand
Faculty of Medicine ,Vajira hospital,Navamindradhiraj University
Bangkok, Thailand, 10300
Sponsors and Collaborators
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Investigators
Principal Investigator: Thananda Trakarnvanich, MD Faculty of Medicine,Vajira Hospital,Navamindradhiraj University

Responsible Party: Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier: NCT03470727     History of Changes
Other Study ID Numbers: 71/2560
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Citric Acid
Dialysis Solutions
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions