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

Sponsor

Shanghai Changzheng Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02264964

Collaborator

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

1,400

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Device: GamCath® Procedure: Arteriovenous fistula creation Device: GamCath® Procedure: Arteriovenous fistula creation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1400 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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 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

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 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

Outcome Measures

Primary Outcome Measures

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

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