Infections Related Central Venous Catheters (CVL)
| Tracking Information | |||||
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| First Received Date ICMJE | November 5, 2007 | ||||
| Last Updated Date | June 10, 2009 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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: six months ] | ||||
| Change History | Complete list of historical versions of study NCT00554021 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Physiological data, Laboratory data, and cultured bacterial data. Further study details can be obtained from K NISHIKAWA PhD.,Department of Traumatology and Critical Care Medicine, National Defense Medical College, Japan. (kaho@jk9.so-net.ne.jp) [ Time Frame: six months ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Infections Related Central Venous Catheters | ||||
| Official Title ICMJE | Infections Associated With the Use of Central Venous Catheters Related in Critical Care Center. | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: We will use the DNA from the only clinical isolated bacteria. |
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| Sampling Method | Probability Sample | ||||
| Study Population | Critical Care staff |
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| Condition ICMJE | SIRS | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
Department of Traumatology and Critical Care Medicine, National Defense Medical College |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 14 Years to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00554021 | ||||
| Other Study ID Numbers ICMJE | NDMC-CV0001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kahoko Nishikawa, NDMC | ||||
| Study Sponsor ICMJE | National Defense Medical College, Japan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Defense Medical College, Japan | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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