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

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.

Study Overview

• Status: Recruiting
• Conditions: Clarify the Difference of Short-term Infection Rate Between Diffrent Catheter
• Intervention / Treatment: Procedure: Tunnel-cuffed Catheter; Procedure: Non-ccuffed Catheter

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Wenhu Liu; Phone Number: 15110124629; Email: wenhuliu@mail.ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friedship Hospital
      • Contact: Wenhu Liu, Doctor; Phone Number: +86-01-63139144; Email: liuwh0211@126.com
      • Sub-Investigator: Zongli Diao, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient who needs hemodialysis with catheter in right internal jugular vein

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tunnel-cuffed Catheter Group; Hemodialysis patient with Tunnel-cuffed Catheter in right internal jugular vein	Procedure: Tunnel-cuffed Catheter; Tunnel-cuffed Catheter in right internal jugular vein
Non-ccuffed Catheter Group; Hemodialysis patient with Non-cuffed Catheter in right internal jugular vein	Procedure: Non-ccuffed Catheter; Non-ccuffed Catheter in right internal jugular vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of catheter infection within 3 months after catheterization	Cumulative incidence of catheter infection within 3 months after catheterization	within 3 months after catheterization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of catheter infection within 2 months after catheterization	Cumulative incidence of catheter infection within 2 months after catheterization	within 2 months after catheterization
Cumulative incidence of catheter infection within 1 months after catheterization	Cumulative incidence of catheter infection within 1 months after catheterization	within 1 months after catheterization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of catheter dysfunction	The incidence of catheter dysfunction	within 3 months after catheterization

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BFHHZML20230013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No