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

Phase 3

• Conditions: Catheter loss due to CRT or CRBSI; Catheter lock; Catheter related blood stream infection; Catheter related thrombosis; End stage renal disease; Sodium bicarbonate; Heparin

• Registration Number: TCTR20200610003
• Lead Sponsor: Grant for research, Faculty of medicine, Chulalongkorn university

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-10
• Study Completion: 2021-06-30
• Results First Posted: 2021-08-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated (Halted Prematurely)
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Catheter loss rate due to CRBSI and CRT 0, 3, 6 months record events per 6 months

Secondary Outcome Measures

Name	Time	Method
Composite outcome of CRT, CRBSI, or ESI/TI rate 0, 3, 6 month percentage