Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock
Comparison Between Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock With Undefined Origin
2 other identifiers
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 18, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedSeptember 20, 2013
September 1, 2013
10 months
September 18, 2013
September 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infection resolution
Compare the resolution of CVC-related infection between the group that had the CVC exchanged, versus the CVC-maintenance plus adding antibiotics therapy group.
4 weeks
Secondary Outcomes (1)
Clinical variables
6 months
Study Arms (2)
CVC exchange
ACTIVE COMPARATORThe CVC will be removed immediately.
CVC maintenance
EXPERIMENTALThe CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis
Interventions
CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcio M Boniatti, PhD
Hospital Nossa Senhora da Conceicao
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 18, 2013
First Posted
September 20, 2013
Study Start
March 1, 2013
Primary Completion
January 1, 2014
Study Completion
February 1, 2014
Last Updated
September 20, 2013
Record last verified: 2013-09