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

July 21, 2022 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4% sodium citrate group
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

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.

Other Names:
  • there is no other intervention names
Active Comparator: 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.
Drug: 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.
Other Names:
  • there is no other intervention names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central venous catheter exchanges
Time Frame: 3 months
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.
Time Frame: 3 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

December 26, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB No.: 202100060A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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