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| ID | Type | Description | Link |
|---|---|---|---|
| HNSC022014 | Registry Identifier | 022014 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVC exchange | Active Comparator | The CVC will be removed immediately. |
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| CVC maintenance | Experimental | The CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVC exchange | Procedure | CVC exchange when related infection is suspected |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcio M Boniatti, PhD | Contact | 555133572221 | marciobt@terra.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Marcio M Boniatti, PhD | Hospital Nossa Senhora da Conceicao | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nossa Senhora da Conceicao | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| CVC maintenance |
| Drug |
CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC |
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