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

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03470727

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective comparison studyprospective 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 :

Sep 1, 2017

Actual Primary Completion Date :

Dec 30, 2017

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Effect of citrate dialysate to anemia [3 months]
Hemoglobin in gram per dL

Secondary Outcome Measures

Effect of citrate dialysate to dialyzer clotting [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 [3 months]
electrolyte in mmoll/L(Sodium,Potassium,Chloride and bicarbonate)
effect of citrate dialysate to dialysis adequacy [3 months]
Kt/V

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital

ClinicalTrials.gov Identifier:

NCT03470727

Other Study ID Numbers:

71/2560

First Posted:

Mar 20, 2018

Last Update Posted:

Mar 20, 2018

Last Verified:

Mar 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anemia

Dialysis Solutions

Study Results

No Results Posted as of Mar 20, 2018