NCT00554021

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

3 months

First QC Date

November 5, 2007

Last Update Submit

June 10, 2009

Conditions

SIRS

Keywords

Central venous catheternosocomial infection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1

Department of Traumatology and Critical Care Medicine, National Defense Medical College

Eligibility Criteria

Age14 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critical Care staff

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Traumatology and Critical Care of Medicine

Tokorozawa, Saitama, 359-8513, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kahoko NISHIKAWA, PHD

    National Defense Medical College

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

November 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

JP(1)