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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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internal jugular vein catheterization

900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation.

Group Type EXPERIMENTAL

GamCath®

Intervention Type DEVICE

Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.

Arteriovenous fistula creation

Intervention Type PROCEDURE

900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.

femoral vein catheterization

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.

Group Type EXPERIMENTAL

GamCath®

Intervention Type DEVICE

Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.

Arteriovenous fistula creation

Intervention Type PROCEDURE

500 patients will undergo AVF creation in either arm for femoral vein catheterization group.

Interventions

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GamCath®

Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.

Intervention Type DEVICE

Arteriovenous fistula creation

500 patients will undergo AVF creation in either arm for femoral vein catheterization group.

Intervention Type PROCEDURE

GamCath®

Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.

Intervention Type DEVICE

Arteriovenous fistula creation

900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.

Intervention Type PROCEDURE

Other Intervention Names

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radiopaque catheter(11F) polyurethane Arteriovenous fistulization AVF creation radiopaque catheter(11F) polyurethane with curved extension lines Arteriovenous fistulization AVF creation

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No