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

Not Applicable

• Conditions: Venous Thrombosis; Central Venous Catheterization; Renal Failure Chronic Requiring Hemodialysis; Venous Stenosis; Central Venous Catheter Thrombosis; Inadequate Hemodialysis Blood Flow; Infection Due to Central Venous Catheter
• Interventions: Device: GamCath®; Procedure: Arteriovenous fistula creation

• Registration Number: NCT02264964
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-23
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-09
• Last Update Submitted: 2014-10-09
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-15
• Study Start: 2015-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Bloodstream infection due to central venous catheter	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	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Inadequate hemodialysis blood flow	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
Central venous catheter thrombosis	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
venous thrombosis	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.
venous stenosis	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	up to 3 months	Participants will be followed-up during non-cuffed catheter retention, an expected up to 3 months.

Secondary Outcome Measures

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