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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00554021
Other study ID # NDMC-CV0001
Secondary ID
Status Completed
Phase N/A
First received November 5, 2007
Last updated June 10, 2009
Start date November 2007
Est. completion date February 2008

Study information

Verified date June 2009
Source National Defense Medical College, Japan
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

The purpose of this study is to clarify the relationship between SIRS (Systemic inflammatory response syndrome) and the infection associated with the use of central venous catheters at Critical Care center in National Defense Medical College, Japan.


Description:

The doctor would remove the inserted catheter from the patient, if the patient shows SIRS. At the same time, the tip of used catheter and blood from the patient are checked whether the pathogenic bacteria exists or not by general bacterial protocol and blood culture test on a routine application. Unfortunately, these tests not always clarified their cause of SIRS. Therefore we conduct this investigation to establish the useful protocol for pathogenic bacteria. We check the pathogenic bacteria not only tip but through the whole catheter in Central Venous Catheter using general bacterial protocol and SEM observation. Additionally, we compared that sputum, urine, skin and blood from the patient for bacteria check.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 95 Years
Eligibility Inclusion Criteria:

- A patient has been inserted with central venous line over 24 hours.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Department of Traumatology and Critical Care of Medicine Tokorozawa Saitama

Sponsors (1)

Lead Sponsor Collaborator
National Defense Medical College, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Culture of bacteria with in central venous catheter. Morbidity and mortality of a patient with multiple resistant bacteria associated with use of the catheter. four months No
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