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

October 9, 2014 updated by: Changlin Mei, Shanghai Changzheng Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: GamCath®
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
Other Names:
  • radiopaque catheter(11F) polyurethane
Procedure: Arteriovenous fistula creation
500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
Other Names:
  • Arteriovenous fistulization
  • AVF creation
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.
Other Names:
  • radiopaque catheter(11F) polyurethane with curved extension lines
Procedure: Arteriovenous fistula creation
900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.
Other Names:
  • Arteriovenous fistulization
  • 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.
Device: GamCath®
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
Other Names:
  • radiopaque catheter(11F) polyurethane
Procedure: Arteriovenous fistula creation
500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
Other Names:
  • Arteriovenous fistulization
  • AVF creation
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.
Other Names:
  • radiopaque catheter(11F) polyurethane with curved extension lines
Procedure: Arteriovenous fistula creation
900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.
Other Names:
  • Arteriovenous fistulization
  • AVF creation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
From baseline to 6months
Safety Evaluation
Time Frame: From baseline to 6months
adverse event or serious adverse event
From baseline to 6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Collaborators

First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Zhengzhou University
Zhongda Hospital
Sichuan Provincial People's Hospital
Beijing Haidian Hospital
The Second Affiliated Hospital of Dalian Medical University

Investigators

  • Principal Investigator: Changlin Mei, master, Division of Nephrology, Shanghai ChangZheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZHKI-HDVA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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