Clinical trial NCT02264964: Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis
Official title: Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis
Central Venous Catheterization
Inadequate Hemodialysis Blood Flow
Venous Stenosis
Venous Thrombosis
Infection Due to Central Venous Catheter
Central Venous Catheter Thrombosis
Keywords: Hemodialysis
End-Stage Kidney Disease
Central Venous Catheterization
Digital Subtraction Angiography
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: Zhongda Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Sichuan Provincial People's Hospital
name: The Second Affiliated Hospital of Dalian Medical University
name: Beijing Haidian Hospital
First posted: 2014-10-15
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. Totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. Every patient will be followed-up for six months. During following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. The central vein will be evaluated by CT Angiography to identify its stenosis at last visit after 6 months. This multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.


Eligibility criteria: Inclusion Criteria:

* Chronic renal failure requiring hemodialysis.
* No medical history of central vena catheterization.
* Maintenance hemodialysis after central vena catheterization.
* Signed informed consent.

Exclusion Criteria:

* Had been performed central venous puncture or catheterization before.
* Can not use heparin.
* Refused to sign the informed consent.
* Advanced cancer patients.
* With or will take arteriovenous fistula surgery in right arm.
* Other inappropriate situation

Primary outcomes:
measure: Bloodstream infection due to central venous catheter
timeFrame: up to 3 months
measure: Central venous catheter exit site infection
timeFrame: up to 3 months
measure: Inadequate hemodialysis blood flow
timeFrame: up to 3 months
measure: Central venous catheter thrombosis
timeFrame: up to 3 months
measure: venous thrombosis
timeFrame: up to 3 months
measure: venous stenosis
timeFrame: up to 3 months
measure: Duration time of non-cuff catheter
timeFrame: up to 3 months
Secondary outcomes:
measure: Long term occurrence of venous stenosis
timeFrame: 6 months
measure: Effects on ECG
timeFrame: From baseline to 6months
measure: Safety Evaluation
timeFrame: From baseline to 6months
Other outcomes:
Locations:
Study officials:
affiliation: Division of Nephrology, Shanghai ChangZheng Hospital
name: Changlin Mei, master
role: PRINCIPAL_INVESTIGATOR
References: