Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis

• Sponsor: Shanghai Pudong Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04399564
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Days): 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stenosis of Arteriovenous Dialysis Fistula	Device: temporary hemodialysis catheters; Device: long-term hemodialysis catheters	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized controlled trialrandomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis in Long-term Hemodialysis Patients
• Anticipated Study Start Date: May 25, 2021
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: temporary hemodialysis catheters one arm-temporary hemodialysis catheter	Device: temporary hemodialysis catheters; Vascular access using temporary vs.long-term hemodialysis catheters
Experimental: long-term hemodialysis catheters another arm-long term hemodialysis catheter	Device: long-term hemodialysis catheters; long-term hemodialysis catheters

Outcome Measures

Primary Outcome Measures

1. 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

1. time of infection [8 weeks]

   infected in temporary or long-term hemodialysis catheters

2. catheter unobstructed degree [8 weeks]

   blood flow in hemodialysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Pudong Hospital

Investigators

• Principal Investigator: Hui Min Jin, MD, Shanghai Pudong Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Pudong Hospital
• ClinicalTrials.gov Identifier: NCT04399564
• Other Study ID Numbers: ShanghaiPudongH3
• First Posted: May 22, 2020
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai Pudong Hospital: central vein stenosis; temporary hemodialysis catheters; long term hemodialysis catheter
• Additional relevant MeSH terms: Constriction, Pathologic; Fistula

Study Results

No Results Posted as of Mar 17, 2021