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Infections Related Central Venous Catheters (CVL)

This study has been completed.
Sponsor:
Information provided by:
National Defense Medical College, Japan
ClinicalTrials.gov Identifier:
NCT00554021
First received: November 5, 2007
Last updated: June 10, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition
SIRS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Infections Associated With the Use of Central Venous Catheters Related in Critical Care Center.

Resource links provided by NLM:

MedlinePlus related topics: Critical Care
U.S. FDA Resources

Further study details as provided by National Defense Medical College, Japan:

Primary Outcome Measures:
  • Culture of bacteria with in central venous catheter. Morbidity and mortality of a patient with multiple resistant bacteria associated with use of the catheter. [ Time Frame: four months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

We will use the DNA from the only clinical isolated bacteria.


Estimated Enrollment: 60
Study Start Date: November 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Department of Traumatology and Critical Care Medicine, National Defense Medical College

Detailed 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.

  Eligibility

Ages Eligible for Study:   14 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Critical Care staff

Criteria

Inclusion Criteria:

  • A patient has been inserted with central venous line over 24 hours.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554021

Locations
Japan
Department of Traumatology and Critical Care of Medicine
Tokorozawa, Saitama, Japan, 359-8513
Sponsors and Collaborators
National Defense Medical College, Japan
Investigators
Study Director: Kahoko NISHIKAWA, PHD National Defense Medical College
  More Information

No publications provided

Responsible Party: Kahoko Nishikawa, NDMC
ClinicalTrials.gov Identifier: NCT00554021     History of Changes
Other Study ID Numbers: NDMC-CV0001
Study First Received: November 5, 2007
Last Updated: June 10, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by National Defense Medical College, Japan:
Central venous catheter
nosocomial infection

ClinicalTrials.gov processed this record on May 21, 2013