Catheter Related InfectionNCT01947751
Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock
A study testing CVC exchange and CVC maintenance in people with Catheter Related Infection, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Catheter Related Infection
- What is being tested?
- CVC exchange and CVC maintenance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul
Marcio M Boniatti, PhD, 555133572221, marciobt@terra.com.br
Marcio M Boniatti, PhD
About this study
Official title: Comparison Between Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock With Undefined Origin
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.
Read the 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.
- Conditions
- Catheter Related Infection
- Being tested
- CVC exchange, CVC maintenance
- Keywords
- Catheter related infection, Central venous catheter, CVC infection
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVC exchangeProcedure or surgery
CVC exchange when related infection is suspected
CVC maintenanceDrug
Also called Watchful waiting strategy
CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC
| Study group | Role | What they receive |
|---|---|---|
| CVC exchange | Active comparator | The CVC will be removed immediately. Receives: Procedure: CVC exchange |
| CVC maintenance | Experimental | The CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis Receives: Drug: CVC maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcio Manozzo Boniatti, Hospital Nossa Senhora da Conceicao
- Investigators
- Marcio M Boniatti, PhD, Principal investigator, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947751
- Sponsor's protocol ID
- HNSConceicao
- Other IDs
- HNSC022014
- Status last verified
- Sep 2013
- First submitted
- 18 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Catheter Early Withdrawal or Maintenance in Sepsis or Septic Shock With Undefined Origin
- ClinicalTrials.gov ID
- NCT01947751
- Acronym / sponsor ID
- HNSConceicao
- Conditions
- Catheter Related Infection
- Keywords
- Catheter related infection, Central venous catheter, CVC infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVC exchange | Active comparator | Procedure: CVC exchangeThe CVC will be removed immediately. |
| CVC maintenance | Experimental | Drug: CVC maintenanceThe CVC will be maintained, and exchanged only if confirmed catheter-related infection or worsening of sepsis |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVC exchangeCVC exchange when related infection is suspected | Procedure or surgery | CVC exchange |
| CVC maintenanceAlso: Watchful waiting strategyCVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC | Drug | CVC maintenance |
Primary outcome
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.
1 secondary outcome
Clinical variables
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcio M Boniatti, PhD principal investigator
Hospital Nossa Senhora da Conceicao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVC exchange and CVC maintenance in people with Catheter Related Infection, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcio M Boniatti, PhD (555133572221, marciobt@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection resolution (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.