The Effectiveness and Safety of 4% Sodium Citrate as a Lock Solution in Central Venous Hemodialysis Catheter

Study Overview
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Brief Summary
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Studies that used a dilute citrate formulation (4%) demonstrated efficacy as an anticoagulant with minimal to no risk of bleeding in HD sessions. This study will compare effectiveness and safety utilizing 4% sodium citrate vs. heparin as a lock solution in central venous hemodialysis catheter among hemodialysis patients.

Detailed Description
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Vascular access is necessary for hemodialysis(HD) procedure. In normal situation, vascular access for HD is created in peripheral vessels. However, vascular catheter may be considered in patients without available peripheral vessels for vascular access. The characteristic of these patients include elderly, diabetes, not tolerant to vascular surgery etc.. Commonly, the HD catheter is inserted in the central vein in these population. Considering clotting condition, anticoagulant is indicated for catheter locking after HD session. In the past years, heparin is the most common solution to be used as locking solution. Nevertheless, heparin has a few disadvantages, such as systemic anticoagulation, thrombocytopenia, and bleeding risk. An alternative for anticoagulation in HD session is 4% sodium citrate. The effectiveness and safety of sodium citrate in HD sessions have been reported in clinical studies. Characteristics of sodium citrate and safety profile Trisodium citrate acts locally as an anticoagulant by chelating ionized calcium in blood, resulting in the blockage of calcium-dependent clotting pathways. Studies that used a dilute citrate formulation (4%) demonstrated efficacy as an anticoagulant with minimal to no risk of bleeding in HD sessions. The advantageous effects of sodium citrate in HD catheter locking solution includes reducing frequency of catheter exchanges, reducing using of thrombolytic drugs, reducing hospitalization rates, and bacteremia. Regarding adverse effect of sodium citrate, hypocalcemia and other untoward outcomes are rare reported in the previous clinical studies

Official Title
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Compare Effectiveness and Safety Utilizing 4% Sodium Citrate vs. Heparin as a Lock Solution in Central Venous Hemodialysis Catheter Among Hemodialysis Patients

Conditions
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Central Venous Catheter Thrombosis, Renal Dialysis

Intervention / Treatment
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* Drug: 4% sodium citrate
* Drug: heparin group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=20 years End-stage renal disease patients who received regular HD weekly via central venous catheter for at least 3 months in outpatient clinic in Kaohsiung Chang Gung Memorial Hospital, Taiwan Exclusion Criteria: bleeding tendency on radiotherapy or chemotherapy for malignancy pregnancy drug allergy history to citrate undefined reasons for refuted participation.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4% sodium citrate group<br>Dose of 4% sodium citrate is also according to catheter lumen (LVR) instilled into each lumen of catheter after HD session, eg. 1.6 cc/lumen for LV R 1.6, 1.8 cc/lumen for LVR 1.8. | Drug: 4% sodium citrate<br>* Dose of 4% sodium citrate is also according to catheter lumen (LVR) instilled into each lumen of catheter after HD session, eg. 1.6 cc/lumen for LV R 1.6, 1.8 cc/lumen for LVR 1.8. A prospective, open label, control study. The content of study protocol will be posted in the HD room in the Kaohsiung Chang Gung memorial Hospital, Taiwan. After inform consent obtained, we will categorize enrolled participants randomly into two groups, 4% sodium citrate group(experimental group), heparin group(control group), respectively. The study duration is three months.<br>* Other names: there is no other intervention names;|
| Active Comparator: heparin group<br>Heparin dosage is based on volume ratio in catheter lumen (LVR) after each HD session, eg. 8000u/lumen in 1.6 LVR, 9000u/lumen in LVR 1.8. | Drug: heparin group<br>* Heparin dosage is based on volume ratio in catheter lumen (LVR) after each HD session, eg. 8000u/lumen in 1.6 LVR, 9000u/lumen in LVR 1.8.<br>* Other names: there is no other intervention names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central venous catheter exchanges | We will record the episode of central venous catheter malfunction and central venous catheter exchanges within the period of trial and compare the incidence between two arms. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| events of thrombolytic drug use, bacteremia and all-cause hospitalization days. | We will record the episode of central venous catheter malfunction and events of thrombolytic drug use within the period of trial and compare the incidence between two arms. We will also compare the incidence of bacteremia and all-cause hospitalization days within these 3 months. | 3 months |