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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01434797
Other study ID # 89/11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2011
Est. completion date March 2020

Study information

Verified date March 2020
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study hypothesis is that F-18-FDG PET/CT and microcalorimetry might have a diagnostic value in the detection of permanent central venous catheters (PCVC) infection when conventional means of PCVC infection detection are non-conclusive.


Description:

Permanent central venous catheters are frequently infected and therefore need surgical removal. When a clear diagnostic for infection cannot be defined, catheter removal might be at risk for the patient, for the therapeutic follow-up and in terms of costs. PET/CT and microcalorimetry might help giving conclusive diagnostic of catheter infection.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date March 2020
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with confirmed catheter infection requiring surgical removal

- patients with probable catheter infection requiring surgical removal

- patients with planned removal of uninfected catheter

- =18years old

Exclusion Criteria:

- extreme claustrophobia

- pregnancy and breastfeeding

- severe septicemia

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Centre Hospitalier Universitaire Vaudois, Nuclear Medicine Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of F-18-FDG PET/CT imaging in the detection of CVCP infection To determine the clinical use of PET/CT in the detection of catheter infection by comparing PET/CT imaging results to standard means of catheter infection detection (i.e. clinical signs and hemoculture [positive or negative]) 6 months
Secondary Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of microcalorimetry in the detection of CVCP infection To determine the clinical use of microcalorimetry in the detection of catheter infection by comparing microcalorimetry results to standard means of catheter infection detection (i.e. clinical signs and hemoculture [positive or negative]) 6 months
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