Bloodstream Infection Due to Central Venous CatheterNCT01481038
Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections
An observational study of Bloodstream Infection Due to Central Venous Catheter, run by Medical University of Graz at 1 site in Austria.
Trial summary
Up to date methods for diagnosis of Catheter Related Bloodstream Infections (CRBSI) are performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis or septic embolism when diagnostic procedures… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection Due to Central Venous Catheter
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2011to May 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing hemodialysis using a central venous catheter and Patients with underlying hematooncologic disease with central venous catheters
Who may be able to join
- Patients undergoing hemodialysis using a central venous catheter and
- Patients with underlying hematooncologic disease with central venous catheters
Who cannot join
- No central venous catheter
- Current CRBSI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections Using Biphasic PNA FISH and Gram Stain/AOLC Tests
Up to date methods for diagnosis of Catheter Related Bloodstream Infections (CRBSI) are performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis or septic embolism when diagnostic procedures for the detection of CRBSI are introduced. The aim of the project is to investigate a more sensitive and specific test for anticipative diagnosis of CRBSI using biphasic PNA FISH test compared to Gram stain/AOLC test.
Read the detailed description
Management of patients with hematologic malignancies, renal failure or diseases requiring intensive care often necessitates the use of central venous catheters (CVC). Beside obvious advantages CVCs bear a great risk for local or systemic infections. In the US estimated 250 000 catheter-related blood stream infection (CRBSIs) occur each year with mortality rates of 12-25%. Diagnosis of CRBSIs remains challenging as systemic clinical signs are unspecific and local signs of infection are often absent. Conventional methods for diagnosing CRBSIs require removal of the CVC. However, only 15% of CVCs removed in patients with clinical suspicion of CRBSI prove to be infected. It has been shown that CRBSI can also be detected by the differential time to positivity (DTP) method without catheter removal. The Gram stain/acridine-orange leukocyte cytospin (AOLC) test and PNA FISH test are another methods for the diagnosis of CRBSI that does not require the removal of the CVC and additionally have shown to be fast. Up to date methods for diagnosis of CRBSI are performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis or septic embolism when diagnostic procedures for the detection of CRBSI are introduced. Since CRBSIs are not entirely preventable by strict hygiene measures earlier diagnosis of CRBSI in subclinical stages is desirable to avoid CRBSI-associated morbidity and mortality. Previously a pilot study showed that Gram stain/AOLC screening of CVCs in neutropenic patients was a useful test to predict the development of CRBSI on average 48 hours before the diagnosis was established by routine measures. In the pilot study Gram stain/AOLC screening test exhibited high specificity whereas sensitivity was moderate. PNA FISH is a specific slide-based staining technique that provides pathogen identification from blood samples containing a given amount of bacteria or fungi within a 1,5 hours. PNA FISH test has a slightly lower detection limit compared to Gram stain/AOLC which might therefore result in higher sensitivity when used as a screening tool. The aim of the project is to investigate a more sensitive and specific test for anticipative diagnosis of CRBSI using biphasic PNA FISH test compared to Gram stain/AOLC test.
- Keywords
- early detection, CRBSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group dialysis patients | Patient on hemodialysis with central venous catheter | |
| Group hematology patients | Patients with hemato-oncologic underlying disease (plus/minus hematopoietic stem cell transplantation HSCT) and central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of crbsi
There is only one outcome measure that is evaluated in two patient cohorts. Screening of catheter blood for microbial burden is performed during the whole study. Outcome measure is the development of CRBSI in these screened patients. Patients on hemodialysis using a CVC will be screened and observed for an sheduled time of approx. 1,5 years or until the CVC will be removed and hemodialysis no longer necessary. Patients undergoing HSCT will be screened and observed until CVC will be removed.
Measured: Participants will be followed for the development of CRBSI during the duration of central venous catheter usage, an expected average of 1 year in hemodialysis patients and an expected average of six weeks in HSCT patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream Infection Due to Central Venous CatheterStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Krause, MD, Medical University of Graz
- Investigators
- Robert Krause, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481038
- Sponsor's protocol ID
- CRBSI FFG Bridge
- Status last verified
- May 2016
- First submitted
- 16 Nov 2011
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections Using Biphasic PNA FISH and Gram Stain/AOLC Tests
- ClinicalTrials.gov ID
- NCT01481038
- Acronym / sponsor ID
- CRBSI FFG Bridge
- Keywords
- early detection, CRBSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Nov 2011 (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.
Up to date methods for diagnosis of Catheter Related Bloodstream Infections (CRBSI) are performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis or septic embolism when diagnostic procedures for the detection of CRBSI are introduced. The aim of the project is to investigate a more sensitive and specific test for anticipative diagnosis of CRBSI using biphasic PNA FISH test compared to Gram stain/AOLC test.
Detailed description
Management of patients with hematologic malignancies, renal failure or diseases requiring intensive care often necessitates the use of central venous catheters (CVC). Beside obvious advantages CVCs bear a great risk for local or systemic infections. In the US estimated 250 000 catheter-related blood stream infection (CRBSIs) occur each year with mortality rates of 12-25%. Diagnosis of CRBSIs remains challenging as systemic clinical signs are unspecific and local signs of infection are often absent. Conventional methods for diagnosing CRBSIs require removal of the CVC. However, only 15% of CVCs removed in patients with clinical suspicion of CRBSI prove to be infected. It has been shown that CRBSI can also be detected by the differential time to positivity (DTP) method without catheter removal. The Gram stain/acridine-orange leukocyte cytospin (AOLC) test and PNA FISH test are another methods for the diagnosis of CRBSI that does not require the removal of the CVC and additionally have shown to be fast. Up to date methods for diagnosis of CRBSI are performed only when CRBSI is clinically suspected. Thus, patients may actually suffer from CRBSI and are at risk to concurrently suffer from or develop complications like endocarditis or septic embolism when diagnostic procedures for the detection of CRBSI are introduced. Since CRBSIs are not entirely preventable by strict hygiene measures earlier diagnosis of CRBSI in subclinical stages is desirable to avoid CRBSI-associated morbidity and mortality. Previously a pilot study showed that Gram stain/AOLC screening of CVCs in neutropenic patients was a useful test to predict the development of CRBSI on average 48 hours before the diagnosis was established by routine measures. In the pilot study Gram stain/AOLC screening test exhibited high specificity whereas sensitivity was moderate. PNA FISH is a specific slide-based staining technique that provides pathogen identification from blood samples containing a given amount of bacteria or fungi within a 1,5 hours. PNA FISH test has a slightly lower detection limit compared to Gram stain/AOLC which might therefore result in higher sensitivity when used as a screening tool. The aim of the project is to investigate a more sensitive and specific test for anticipative diagnosis of CRBSI using biphasic PNA FISH test compared to Gram stain/AOLC test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group dialysis patients | – | –Patient on hemodialysis with central venous catheter |
| Group hematology patients | – | –Patients with hemato-oncologic underlying disease (plus/minus hematopoietic stem cell transplantation HSCT) and central venous catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing hemodialysis using a central venous catheter and Patients with underlying hematooncologic disease with central venous catheters
Key inclusion criteria (2 listed)
- Patients undergoing hemodialysis using a central venous catheter and
- Patients with underlying hematooncologic disease with central venous catheters
Key exclusion criteria (2 listed)
- No central venous catheter
- Current CRBSI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
development of crbsi
Time frame: Participants will be followed for the development of CRBSI during the duration of central venous catheter usage, an expected average of 1 year in hemodialysis patients and an expected average of six weeks in HSCT patients.
There is only one outcome measure that is evaluated in two patient cohorts. Screening of catheter blood for microbial burden is performed during the whole study. Outcome measure is the development of CRBSI in these screened patients. Patients on hemodialysis using a CVC will be screened and observed for an sheduled time of approx. 1,5 years or until the CVC will be removed and hemodialysis no longer necessary. Patients undergoing HSCT will be screened and observed until CVC will be removed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
Related trials for Bloodstream Infection Due to Central Venous Catheter
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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.
Robert Krause, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection Due to Central Venous Catheter, run by Medical University of Graz at 1 site in Austria.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2016. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of crbsi (time frame: Participants will be followed for the development of CRBSI during the duration of central venous catheter usage, an expected average of 1 year in hemodialysis patients and an expected average of six weeks in HSCT patients.). 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 3 May 2016.