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

NCT03470727 | Completed

• 1 other identifier: 71/2560
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Citrate; Heparin

Outcome Measures

Primary Outcomes (1)

• Effect of citrate dialysate to anemia

  Hemoglobin in gram per dL

  3 months

Secondary Outcomes (3)

• Effect of citrate dialysate to dialyzer clotting

  3 months

• effect of citrate dialysate to electrolyte changes

  3 months

• effect of citrate dialysate to dialysis adequacy

  3 months

Study Arms (1)

Citrate arm

EXPERIMENTAL

Citrate dialysate Phase 1 : Reduce heparin to 50% Phase 2: Reduce heparin to 25% Phase 3: Heparin free

Device: Citrate dialysate

Interventions

Citrate dialysate DEVICE

Change form acetate to citrate dialysate

Citrate arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Bangkok, 10300, Thailand

Location

Study Officials

• Thananda Trakarnvanich, MD

  Faculty of Medicine,Vajira Hospital,Navamindradhiraj University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: prospective comparison study

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 20, 2018
• Study Start: September 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 31, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

TH (1)