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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Bloodstream infection due to central venous catheter
    • Time Frame: up to 3 months
    • Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
  • Central venous catheter exit site infection
    • Time Frame: up to 3 months
    • Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
  • Inadequate hemodialysis blood flow
    • Time Frame: up to 3 months
    • Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
  • Central venous catheter thrombosis
    • Time Frame: up to 3 months
    • Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
  • venous thrombosis
    • Time Frame: up to 3 months
    • Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
  • venous stenosis
    • Time Frame: up to 3 months
    • Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
  • Duration time of non-cuff catheter
    • Time Frame: up to 3 months
    • Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Changzheng Hospital
  • Collaborator
    • First Affiliated Hospital of Zhejiang University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Changlin Mei, Professor, Director, Division of Nephrology – Shanghai Changzheng Hospital
  • Overall Official(s)
    • Changlin Mei, master, Principal Investigator, Division of Nephrology, Shanghai ChangZheng Hospital
  • Overall Contact(s)
    • Yiyi Ma, master, +8613661679863, dukemm@126.com

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