Back to resultsCatheter Early Withdrawal or Maintenance in Sepsis or Septic Shock
Primary Purpose
Catheter Related Infection
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CVC exchange
CVC maintenance
Sponsored by
About this trial
This is an interventional treatment trial for Catheter Related Infection focused on measuring Catheter related infection, Central venous catheter, CVC infection
Eligibility Criteria
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.
Sites / Locations
- Hospital Nossa Senhora da ConceicaoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CVC exchange
CVC maintenance
Arm Description
The CVC will be removed immediately.
The CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinical variables
Comparison of PCR, leukocytes, temperature, length of stay and mortality in the two groups, as well as complication rates and number of catheters removed.
Full Information
NCT ID
NCT01947751
First Posted
September 18, 2013
Last Updated
September 19, 2013
Sponsor
Hospital Nossa Senhora da Conceicao
1. Study Identification
Unique Protocol Identification Number
NCT01947751
Brief Title
Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock
Official Title
Comparison Between Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock With Undefined Origin
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Nossa Senhora da Conceicao
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Related Infection
Keywords
Catheter related infection, Central venous catheter, CVC infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CVC exchange
Arm Type
Active Comparator
Arm Description
The CVC will be removed immediately.
Arm Title
CVC maintenance
Arm Type
Experimental
Arm Description
The CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis
Intervention Type
Procedure
Intervention Name(s)
CVC exchange
Intervention Description
CVC exchange when related infection is suspected
Intervention Type
Drug
Intervention Name(s)
CVC maintenance
Other Intervention Name(s)
Watchful waiting strategy
Intervention Description
CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC
Primary Outcome Measure Information:
Title
Infection resolution
Description
Compare the resolution of CVC-related infection between the group that had the CVC exchanged, versus the CVC-maintenance plus adding antibiotics therapy group.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Clinical variables
Description
Comparison of PCR, leukocytes, temperature, length of stay and mortality in the two groups, as well as complication rates and number of catheters removed.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcio M Boniatti, PhD
Phone
555133572221
Email
marciobt@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcio M Boniatti, PhD
Organizational Affiliation
Hospital Nossa Senhora da Conceicao
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcio M Boniatti, PhD
Phone
555133572221
Email
marciobt@terra.com.br
First Name & Middle Initial & Last Name & Degree
Marcio M Boniatti, PhD
12. IPD Sharing Statement
Learn more about this trial
Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock
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