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

Renal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05188339
• Other study ID #: IRB No.: 202100060A3
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: July 20, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age >=20 years

2. 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:

1. bleeding tendency

2. on radiotherapy or chemotherapy for malignancy

3. pregnancy

4. drug allergy history to citrate

5. undefined reasons for refuted participation.

Related Conditions & MeSH terms

• Central Venous Catheter Thrombosis
• Renal Dialysis
• Thrombosis
• Upper Extremity Deep Vein Thrombosis

Intervention

Drug:
• 4% sodium citrate
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.
• heparin group
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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