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

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.

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

Interventions

DEVICE

GamCath®

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

PROCEDURE

Arteriovenous fistula creation

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

DEVICE

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.

PROCEDURE

Arteriovenous fistula creation

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Zhongda Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Beijing Haidian Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  lead OTHER

Principal Investigators

• Changlin Mei, master · Division of Nephrology, Shanghai ChangZheng Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2017-12-31

Completion

2017-12-31