Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis

Not Applicable

• Conditions: Stenosis of Arteriovenous Dialysis Fistula
• Interventions: Device: temporary hemodialysis catheters; Device: long-term hemodialysis catheters

• Registration Number: NCT04399564
• Lead Sponsor: Shanghai Pudong Hospital

Brief Summary

Vascular access (VA) is the most important for carrying out hemodialysis, yet it may bring in complications and leads to hemodialysis quality decline. This study aimed to explore the impact of vascular access types, including temporary vs.long term hemodialysis catheter on central vein stenosis.

Detailed Description

It is unknown whether central vein stenosis occurs after temporary or long term hemodialysis catheter in long-term hemodialysis patients. this study will aim to explore this question. Study design is randomized, controlled trial. One arm is temporary catheters in the internal jugular vein, and another arm is tunneled cuffed hemodialysis cather. 2\*2 is randomly distributed.

The main outcome: central vein stenosis diagnosed by venography. The secondary outcome: the time of infection, and catheter patency. Study period: one year

Study Timeline

• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17
• Study Start: 2021-05-25
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• need to receive long-term hemodialysis no arteriovenous shunts or immature arteriovenous shunts

Exclusion Criteria

• Uremia with heart failure or lung function failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
temporary hemodialysis catheters	temporary hemodialysis catheters	one arm-temporary hemodialysis catheter
long-term hemodialysis catheters	long-term hemodialysis catheters	another arm-long term hemodialysis catheter

Primary Outcome Measures

Name	Time	Method
central vein stenosis	8 weeks after temporary or long-term hemodialysis catheter	use of venography as the primary imaging modality for vein mapping

Secondary Outcome Measures

Name	Time	Method
time of infection	8 weeks	infected in temporary or long-term hemodialysis catheters
catheter unobstructed degree	8 weeks	blood flow in hemodialysis