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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,400
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.
900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.
Bloodstream infection due to central venous catheter
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Time frame: up to 3 months
Central venous catheter exit site infection
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Time frame: up to 3 months
Inadequate hemodialysis blood flow
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Time frame: up to 3 months
Central venous catheter thrombosis
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Time frame: up to 3 months
venous thrombosis
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Time frame: up to 3 months
venous stenosis
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Time frame: up to 3 months
Duration time of non-cuff catheter
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Time frame: up to 3 months
Long term occurrence of venous stenosis
CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months.
Time frame: 6 months
Effects on ECG
ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months.
Time frame: From baseline to 6months
Safety Evaluation
adverse event or serious adverse event
Time frame: From baseline to 6months
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