The efficacy and safety of 7.5% Sodium bicarbonate versus Heparin for Locking Solution of Acute temporal dailysis catheter : The randomized control study

Phase 2

• Conditions: Acute kidney injury or chronic kidney injury participants who underwent acute hemodialysis; Locking solution, heparin, 7.5%NaHCO3, sodium bicarbonate, acute kidney injury, chronic kidney disease, heparin lock, hemodialysis, double lumen

• Registration Number: TCTR20200630005
• Lead Sponsor: Vajira hospital research foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-30
• Study Completion: 2020-12-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1.age > 18 yr
2.participants with non cuff venous catheter
3. participants receiving hemodialysis

Exclusion Criteria

1.participants received warfarin, NOAC, or systemic heparin infusion
2.participants with abnormal coagulopathy
3 participants with history of CRBSI at least three months before study
4.participants with history of hypersensitivity to heparin
5. pregnancy
6. participants with low platelet count < 20,000 cells/mm3
7.participants receiving CRRT treatment
8. participants with serum bicarbonate > 30 mmol/dL
9.participants with symptomatic hypocalcemia
10.. participants does not consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy and safety 28 day Catheter day function,Compare rate of complication 28 days Catheter dysfunction; thrombosis, fibrin sleeves, CRBSI

Secondary Outcome Measures

Name	Time	Method
All cause mortality 28 days Incidence rate,Complication due to abnormal bleeding 28 days Incidence rate,Metabolic disturbance ; prolong aPTT, hypoK, hyperHCO3, low serum Ca 28 days Incidence rate