- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01947751
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marcio M Boniatti, PhD
- Phone Number: 555133572221
- Email: marciobt@terra.com.br
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil
- Recruiting
- Hospital Nossa Senhora da Conceição
-
Principal Investigator:
- Marcio M Boniatti, PhD
-
Contact:
- Marcio M Boniatti, PhD
- Phone Number: 555133572221
- Email: marciobt@terra.com.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CVC exchange
The CVC will be removed immediately.
|
CVC exchange when related infection is suspected
|
Experimental: CVC maintenance
The CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis
|
CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infection resolution
Time Frame: 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical variables
Time Frame: 6 months
|
Comparison of PCR, leukocytes, temperature, length of stay and mortality in the two groups, as well as complication rates and number of catheters removed.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marcio M Boniatti, PhD, Hospital Nossa Senhora da Conceição
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HNSConceicao
- HNSC022014 (Registry Identifier: 022014)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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