Duration and Adverse Events of Non-cuffed Catheter in Patients With Hemodialysis
DACAPO
1 other identifier
interventional
1,400
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 15, 2014
October 1, 2014
2.9 years
September 23, 2014
October 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Bloodstream infection due to central venous catheter
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
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
up to 3 months
Inadequate hemodialysis blood flow
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
up to 3 months
Central venous catheter thrombosis
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
up to 3 months
venous thrombosis
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
up to 3 months
venous stenosis
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
Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
up to 3 months
Secondary Outcomes (3)
Long term occurrence of venous stenosis
6 months
Effects on ECG
From baseline to 6months
Safety Evaluation
From baseline to 6months
Study Arms (2)
internal jugular vein catheterization
EXPERIMENTAL900 patients will be received temporary central vena catheterization in right internal jugular vein with non-cuff GamCath® catheter.They will undergo AVF creation.
femoral vein catheterization
EXPERIMENTAL500 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.
Interventions
Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
Eligibility Criteria
You may qualify if:
- Chronic renal failure requiring hemodialysis.
- No medical history of central vena catheterization.
- Maintenance hemodialysis after central vena catheterization.
- Signed informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Changzheng Hospitallead
- First Affiliated Hospital of Zhejiang Universitycollaborator
- Zhongda Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Sichuan Provincial People's Hospitalcollaborator
- The Second Affiliated Hospital of Dalian Medical Universitycollaborator
- Beijing Haidian Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changlin Mei, master
Division of Nephrology, Shanghai ChangZheng Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director, Division of Nephrology
Study Record Dates
First Submitted
September 23, 2014
First Posted
October 15, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
October 15, 2014
Record last verified: 2014-10