Long-term Hemodialysis Catheter Removal and Delayed Replacement, Versus Exchange Over a Guidewire to Treat Catheter Related Blood Stream Infection

NCT ID: NCT03054714

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-01

Study Completion Date

2016-11-30

Brief Summary

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Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed replacement, versus exchange over a guidewire to treat catheter related blood stream infection

Detailed Description

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The aim of this study was to compare the clinical outcomes of catheter-related (CRBSI) managed with two different strategies: Guidewire exchange of the infected catheter with a new one over a guidewire versus catheter removal with delayed replacement.

Conditions

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Catheter Related Blood Stream Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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group A

exchange of the infected catheter with a new one over a guidewire

Group Type ACTIVE_COMPARATOR

catheter replacement

Intervention Type DEVICE

catheter removal and delayed replacement, versus exchange over a guidewire

group B

removal of the infected catheter followed by delayed placement of a new catheter 3 to 10 days later

Group Type ACTIVE_COMPARATOR

catheter replacement

Intervention Type DEVICE

catheter removal and delayed replacement, versus exchange over a guidewire

Interventions

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catheter replacement

catheter removal and delayed replacement, versus exchange over a guidewire

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients end stage renal disease on hemodialysis from tunneled cuffed dialysis catheters with suspected catheter-related bloodstream infection with no identifiable infection source except the catheter were included.

Exclusion Criteria

* metastatic infection,
Minimum Eligible Age

14 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Hossam M. Saleh

Assistant Prof. of vascular surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.

Reference Type DERIVED
PMID: 35363884 (View on PubMed)

Other Identifiers

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tunneled hemodialysis

Identifier Type: -

Identifier Source: org_study_id

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