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Clinical Trials/TCTR20200610003
TCTR20200610003TerminatedPhase 3

A Randomized Controlled Trial of Comparative Efficacy between Sodium Bicarbonate and Heparin as A Locking Solution for Tunneled Central Venous Catheters Among Patients Requiring Maintenance Hemodialysis

Grant for research, Faculty of medicine, Chulalongkorn university0 sites118 target enrollmentStarted: June 10, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Terminated
Sponsor
Enrollment
118
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The present study was stopped early due to an excess of catheter related thrombosis in the sodium bicarbonate group. From the first 6 weeks of follow-up, there were no catheter losses due to CRT or CRBSI in both groups. The sodium bicarbonate group had a significantly higher rate of the secondary composite outcomes and this was entirely caused by CRT with the median time to thrombosis of 23.6 days.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 Years to N/A (No limit) (—)
Sex
All

Inclusion Criteria

  • •1. Patients age more than 18 years old
  • •2. Patients with maintenance chronic hemodialysis at least 2 sessions per week
  • •3. Patients with permanent catheter as vascular access for hemodialysis

Exclusion Criteria

  • •1. Catheter dysfunction at baseline
  • •2. On current anticoagulation therapy
  • •3. Patients with known coagulopathy or hemophilia
  • •4. Patients with cirrhosis Child-Pugh B or C
  • •5. Patients with thrombocytopenia less than 100,000 u/L
  • •6. Patients with central vessel stenosis and vena cava syndrome, previously documented.
  • •7. Patients with heparin-induced thrombocytopenia
  • •8. Patients with unstable condition within 1 month before enrollment
  • •9. Patients with expected life expectancy less than 6 month

Investigators

Sponsor
Grant for research, Faculty of medicine, Chulalongkorn university

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