Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis

Study Overview
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Brief Summary
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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.

Official Title
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Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis : a Multicenter Prospective Cohort Study

Conditions
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Inadequate Hemodialysis Blood Flow, Venous Stenosis, Venous Thrombosis, Infection Due to Central Venous Catheter, Central Venous Catheter Thrombosis, Renal Failure Chronic Requiring Hemodialysis, Central Venous Catheterization

Intervention / Treatment
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* Device: GamCath®
* Procedure: Arteriovenous fistula creation
* Device: GamCath®
* Procedure: Arteriovenous fistula creation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: internal jugular vein catheterization<br>900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation. | Device: GamCath®<br>* Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.<br>* Other names: radiopaque catheter(11F) polyurethane with curved extension lines;Procedure: Arteriovenous fistula creation<br>* 900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.<br>* Other names: AVF creation;|
| Experimental: femoral vein catheterization<br>500 patients will be received temporary central vena catheterization in femoral vein with non-cuff GamCath® catheter, which are unsuitable for right internal jugular vein catheterization.They will undergo AVF creation. | Device: GamCath®<br>* Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.<br>* Other names: radiopaque catheter(11F) polyurethane;Procedure: Arteriovenous fistula creation<br>* 500 patients will undergo AVF creation in either arm for femoral vein catheterization group.<br>* Other names: AVF creation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloodstream infection due to central venous catheter | Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. | 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. | up to 3 months | 
| Inadequate hemodialysis blood flow | Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. | up to 3 months | 
| Central venous catheter thrombosis | Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. | up to 3 months | 
| venous thrombosis | Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. | up to 3 months | 
| venous stenosis | Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months. | 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. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term occurrence of venous stenosis | CT Angiography for punctured vein will be performed to identify vein stenosis in last visit after 6 months. | 6 months | 
| Effects on ECG | ECG will be performed in preoperative, postoperative, catheter removal and last visit after 6 months. | From baseline to 6months | 
| Safety Evaluation | adverse event or serious adverse event | From baseline to 6months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, End-Stage Kidney Disease, Central Venous Catheterization, Digital Subtraction Angiography