Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Robert Krause, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01481038
First received: November 16, 2011
Last updated: August 6, 2014
Last verified: August 2014

November 16, 2011
August 6, 2014
October 2011
December 2014   (final data collection date for 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. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01481038 on ClinicalTrials.gov Archive Site
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Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum samples PBMCs Lung Tissue samples fungi

Non-Probability Sample

Patients undergoing hemodialysis using a central venous catheter and Patients with underlying hematooncologic disease with central venous catheters

Bloodstream Infection Due to Central Venous Catheter
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing hemodialysis using a central venous catheter and
  • Patients with underlying hematooncologic disease with central venous catheters

Exclusion Criteria:

  • No central venous catheter
  • Current CRBSI
Both
18 Years and older
No
Contact: Robert Krause, MD 0043 316 385 81796 robert.krause@medunigraz.at
Austria
 
NCT01481038
CRBSI FFG Bridge
No
Robert Krause, MD, Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Robert Krause, MD Medical University of Graz
Medical University of Graz
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP