Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis

Stenosis of Arteriovenous Dialysis Fistula Clinical Trial

Official title:

Effect of Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis in Long-term Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04399564
• Other study ID #: ShanghaiPudongH3
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: March 2021
• Source: Shanghai Pudong Hospital
• Contact: Hui Min Jin, MD
• Phone: 13917232915
• Email: hmjgli[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Fistula
• Stenosis of Arteriovenous Dialysis Fistula

Intervention

Device:
• temporary hemodialysis catheters
Vascular access using temporary vs.long-term hemodialysis catheters
• long-term hemodialysis catheters
long-term hemodialysis catheters

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pudong Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central vein stenosis	use of venography as the primary imaging modality for vein mapping	8 weeks after temporary or long-term hemodialysis catheter
Secondary	time of infection	infected in temporary or long-term hemodialysis catheters	8 weeks
Secondary	catheter unobstructed degree	blood flow in hemodialysis	8 weeks