Anticipative Diagnosis of Central Venous Catheter Related Bloodstream Infections

NCT01481038 | Completed

• 1 other identifier: CRBSI FFG Bridge
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Bloodstream Infection Due to Central Venous Catheter

Keywords

early detection; CRBSI

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• No central venous catheter
• Current CRBSI

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Stmk, 8036, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples

Study Officials

• Robert Krause, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.Prof.Dr

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 29, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

AU (1)