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Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock

NCT ID: NCT01947751

Last Updated: 2013-09-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-02-28

Brief Summary

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Central venous catheter(CVC)-related infection is an inherent complication of this device that should be treated promptly. However, there are doubts about the need for the immediate withdrawal of CVC while there is still no confirmation of such infection. The aim of this study is to compare the resolution of CVC-related infection, testing two approaches: catheter´s early exchange, when the possibility of related sepsis is considered, versus the maintenance of the CVC and early antibiotic therapy until the infection is confirmed.

Detailed Description

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The aim of this study is to compare the strategy of immediate removal of the catheter with a conservative strategy in resolution of infection in patients with sepsis or septic shock without a defined origin. The investigators intend to demonstrate that the conservative strategy can reduce the rate of unnecessary catheter removal, without increasing morbidity.

In the intervention group the investigators will adopt the conservative strategy, changing the CVC after the confirmation of infection related to it or non-improvement of sepsis. The control group is represented by the patients in whom the CVC is removed early.

Conditions

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Catheter Related Infection

Keywords

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Catheter related infection Central venous catheter CVC infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CVC exchange

The CVC will be removed immediately.

Group Type ACTIVE_COMPARATOR

CVC exchange

Intervention Type PROCEDURE

CVC exchange when related infection is suspected

CVC maintenance

The CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis

Group Type EXPERIMENTAL

CVC maintenance

Intervention Type DRUG

CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC

Interventions

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CVC exchange

CVC exchange when related infection is suspected

Intervention Type PROCEDURE

CVC maintenance

CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC

Intervention Type DRUG

Other Intervention Names

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Watchful waiting strategy

Eligibility Criteria

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Inclusion Criteria

* All patients with 18 years or more, admitted to ICU that had a CVC inserted before or after ICU admission and with infection with undefined origin.

Exclusion Criteria

* Less than 18 years, severe neutropenia (\<500/mm³), intravascular device (pacemaker, prosthetic valve), unequivocal signs of infection on the site of CVC insertion, patients who were terminally ill defined, bacteremia without a known source, refusal to signing the informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Nossa Senhora da Conceicao

OTHER

Sponsor Role lead

Responsible Party

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Marcio Manozzo Boniatti

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcio M Boniatti, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Nossa Senhora da Conceicao

Locations

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Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Marcio M Boniatti, PhD

Role: CONTACT

Phone: 555133572221

Email: [email protected]

Facility Contacts

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Marcio M Boniatti, PhD

Role: primary

Other Identifiers

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HNSC022014

Identifier Type: REGISTRY

Identifier Source: secondary_id

HNSConceicao

Identifier Type: -

Identifier Source: org_study_id