Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock

Hospital Nossa Senhora da Conceicao

Status: Unknown

Conditions: Catheter Related Infection

Treatments: Procedure: CVC exchange; Drug: CVC maintenance

Study type: Interventional

Funder types: Other

Identifiers

NCT01947751

HNSConceicao

HNSC022014 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

CVC exchange

Active Comparator group

Description:

The CVC will be removed immediately.

Treatment:

Procedure: CVC exchange

CVC maintenance

Experimental group

Description:

The CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis

Treatment:

Drug: CVC maintenance