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

Naval Military Medical University (Second Military Medical University)

Status: Unknown

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

Treatments: Device: GamCath®; Procedure: Arteriovenous fistula creation

Study type: Interventional

Funder types: Other

Identifiers

NCT02264964

CZHKI-HDVA-002

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

internal jugular vein catheterization

Experimental group

Description:

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

Treatment:

Procedure: Arteriovenous fistula creation

Procedure: Arteriovenous fistula creation

Device: GamCath®

Device: GamCath®

femoral vein catheterization

Experimental group

Description:

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.

Treatment:

Procedure: Arteriovenous fistula creation

Procedure: Arteriovenous fistula creation

Device: GamCath®

Device: GamCath®