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Trial record 17 of 111 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

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE March 20, 2018
Last Update Posted Date March 20, 2018
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
Effect of citrate dialysate to anemia [ Time Frame: 3 months ]
Hemoglobin in gram per dL
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients
Official Title  ICMJE The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
prospective comparison study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemodialysis
  • Citrate
  • Heparin
Intervention  ICMJE Device: Citrate dialysate
Change form acetate to citrate dialysate
Study Arms  ICMJE Experimental: Citrate arm
Citrate dialysate Phase 1 : Reduce heparin to 50% Phase 2: Reduce heparin to 25% Phase 3: Heparin free
Intervention: Device: Citrate dialysate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2018)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03470727
Other Study ID Numbers  ICMJE 71/2560
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
Study Sponsor  ICMJE Bangkok Metropolitan Administration Medical College and Vajira Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thananda Trakarnvanich, MD Faculty of Medicine,Vajira Hospital,Navamindradhiraj University
PRS Account Bangkok Metropolitan Administration Medical College and Vajira Hospital
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP