Clarify the Difference of Short-term Infection Rate Between Diffrent CatheterNCT06206447
Comparison of Short-term Application of Dialysis Catheter With Tunnel-cuffed Catheter Versus Non-ccuffed Catheter: a Multicenter Prospective Cohort Study
An observational study of Clarify the Difference of Short-term Infection Rate Between Diffrent Catheter, run by Beijing Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clarify the Difference of Short-term Infection Rate Between Diffrent Catheter
- What is being tested?
- Tunnel-cuffed Catheter and Non-ccuffed Catheter
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who needs hemodialysis with catheter in right internal jugular vein
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friedship Hospital
Beijing, Beijing Municipality, 100050
Wenhu Liu, Doctor, +86-01-63139144, liuwh0211@126.com
Zongli Diao, Master
About this 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.
- Being tested
- Tunnel-cuffed Catheter, Non-ccuffed Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunnel-cuffed CatheterProcedure or surgery
Tunnel-cuffed Catheter in right internal jugular vein
Non-ccuffed CatheterProcedure or surgery
Non-ccuffed Catheter in right internal jugular vein
| Study group | Role | What they receive |
|---|---|---|
| Tunnel-cuffed Catheter Group | Hemodialysis patient with Tunnel-cuffed Catheter in right internal jugular vein Receives: Procedure: Tunnel-cuffed Catheter | |
| Non-ccuffed Catheter Group | Hemodialysis patient with Non-cuffed Catheter in right internal jugular vein Receives: Procedure: Non-ccuffed Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of catheter infection within 3 months after catheterization
Cumulative incidence of catheter infection within 3 months after catheterization
Measured: within 3 months after catheterization
Secondary outcomes (2)
Cumulative incidence of catheter infection within 2 months after catheterization
Cumulative incidence of catheter infection within 2 months after catheterization
Measured: 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
Measured: within 1 months after catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Nov 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clarify the Difference of Short-term Infection Rate Between Diffrent CatheterStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206447
- Sponsor's protocol ID
- BFHHZML20230013
- Status last verified
- Oct 2023
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short-term Application of Dialysis Catheter With Tunnel-cuffed Catheter Versus Non-ccuffed Catheter: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06206447
- Acronym / sponsor ID
- BFHHZML20230013
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tunnel-cuffed Catheter Group | – | Procedure: Tunnel-cuffed CatheterHemodialysis patient with Tunnel-cuffed Catheter in right internal jugular vein |
| Non-ccuffed Catheter Group | – | Procedure: Non-ccuffed CatheterHemodialysis patient with Non-cuffed Catheter in right internal jugular vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who needs hemodialysis with catheter in right internal jugular vein
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tunnel-cuffed CatheterTunnel-cuffed Catheter in right internal jugular vein | Procedure or surgery | Tunnel-cuffed Catheter Group |
| Non-ccuffed CatheterNon-ccuffed Catheter in right internal jugular vein | Procedure or surgery | Non-ccuffed Catheter Group |
Primary outcome
Cumulative incidence of catheter infection within 3 months after catheterization
Time frame: within 3 months after catheterization
Cumulative incidence of catheter infection within 3 months after catheterization
2 secondary outcomes
Cumulative incidence of catheter infection within 2 months after catheterization
Time frame: within 2 months after catheterization
Cumulative incidence of catheter infection within 1 months after catheterization
Time frame: within 1 months after catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clarify the Difference of Short-term Infection Rate Between Diffrent Catheter, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenhu Liu (15110124629, wenhuliu@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of catheter infection within 3 months after catheterization (time frame: within 3 months after catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.