Comparison of Short-term Application of Dialysis Catheter With Tunnel-cuffed Catheter Versus Non-ccuffed Catheter: a Multicenter Prospective Cohort Study

Recruiting

• Conditions: Clarify the Difference of Short-term Infection Rate Between Diffrent Catheter
• Interventions: Procedure: Tunnel-cuffed Catheter; Procedure: Non-ccuffed Catheter

• Registration Number: NCT06206447
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

Through a multi-center, prospective cohort study, hemodialysis patients with right internal jugular vein catheterization were collected and divided into tunnel-cuffed catheter group and non-cuffed catheter group according to the types of catheterization. The incidence of catheter infection, thrombosis and other complications between the two groups were compared.To clarify the difference of short-term infection rate between tunnel-cuffed catheter and non-cuffed catheter.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-11-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• ① Age ≥18 years; ② Uremia, clinical evaluation needs to start hemodialysis immediately, and the right internal jugular vein catheterization is the vascular access for the subjects. ③ Subjects who underwent right internal jugular vein catheterization on regular hemodialysis due to poor internal fistula function and the recovery time of internal fistula was ≥4 weeks; ④ Patients with AKI who need renal replacement therapy and underwent catheterization in the right internal jugular vein, and the renal replacement time is ≥4 weeks.

Exclusion Criteria

• ① Subjects with previous history of central venous thrombosis, stenosis, infection, etc. ② The subjects were not dialyzed three times a week; ③ Other subjects with central venous catheterization, including left internal jugular vein, femoral vein and subclavian vein; ④ Those who take immunosuppression for a long time.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tunnel-cuffed Catheter Group	Tunnel-cuffed Catheter	Hemodialysis patient with Tunnel-cuffed Catheter in right internal jugular vein
Non-ccuffed Catheter Group	Non-ccuffed Catheter	Hemodialysis patient with Non-cuffed Catheter in right internal jugular vein

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of catheter infection within 3 months after catheterization	within 3 months after catheterization	Cumulative incidence of catheter infection within 3 months after catheterization

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of catheter infection within 2 months after catheterization	within 2 months after catheterization	Cumulative incidence of catheter infection within 2 months after catheterization
Cumulative incidence of catheter infection within 1 months after catheterization	within 1 months after catheterization	Cumulative incidence of catheter infection within 1 months after catheterization

Trial Locations

Locations (1)

Beijing Friedship Hospital; 🇨🇳 Beijing, Beijing, China