Catheter Related Infection
Conditions
Keywords
Catheter related infection, Central venous catheter, CVC infection
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.
Interventions
PROCEDURECVC exchange
CVC exchange when related infection is suspected
DRUGCVC maintenance
CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC
Sponsors
Hospital Nossa Senhora da Conceicao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection resolution | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical variables | 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. |
Countries
Brazil
Contacts
Primary ContactMarcio M Boniatti, PhD
Outcome results
None listed