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Infections Related Central Venous Catheters (CVL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554021
First Posted: November 6, 2007
Last Update Posted: June 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Defense Medical College, Japan
  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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 95 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kahoko Nishikawa, NDMC
ClinicalTrials.gov Identifier: NCT00554021     History of Changes
Other Study ID Numbers: NDMC-CV0001
First Submitted: November 5, 2007
First Posted: November 6, 2007
Last Update Posted: June 12, 2009
Last Verified: June 2009

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

Additional relevant MeSH terms:
Infection