NCT03054714

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
798

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

5.1 years

First QC Date

February 10, 2017

Last Update Submit

February 21, 2017

Conditions

Catheter Related Blood Stream Infection

Outcome Measures

Primary Outcomes (1)

  • infection free survival

    45 days

Study Arms (2)

group A

ACTIVE COMPARATOR

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

Device: catheter replacement

group B

ACTIVE COMPARATOR

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

Device: catheter replacement

Interventions

catheter replacementDEVICE

catheter removal and delayed replacement, versus exchange over a guidewire

group Agroup B

Eligibility Criteria

Age14 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • metastatic infection,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 35363884DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof. of vascular surgery

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 16, 2017

Study Start

November 1, 2011

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02