Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock

Not Applicable

• Conditions: Catheter Related Infection
• Interventions: Procedure: CVC exchange; Drug: CVC maintenance

• Registration Number: NCT01947751
• Lead Sponsor: Hospital Nossa Senhora da Conceicao

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.

Study Timeline

• Study Start: 2013-03
• Status Verified: 2013-09
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-19
• Last Update Submitted: 2013-09-19
• Study First Posted: 2013-09-20
• Last Update Posted: 2013-09-20
• Primary Completion: 2014-01
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVC exchange	CVC exchange	The CVC will be removed immediately.
CVC maintenance	CVC maintenance	The CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Nossa Senhora da Conceicao; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil