Ventricular Shunt and Drain Infections - Timing of Reimplantation
This study has been completed.
Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00470132
First received: May 3, 2007
Last updated: August 23, 2012
Last verified: August 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 3, 2007 | ||||
| Last Updated Date | August 23, 2012 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00470132 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ventricular Shunt and Drain Infections - Timing of Reimplantation | ||||
| Official Title ICMJE | Ventricular Shunt and Drain Infections - Timing of Reimplantation | ||||
| Brief Summary | The retrospective study will help determine whether or not placement of new devices prior to the recommended time was associated with a high risk of relapse or treatment failure. |
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| Detailed Description | The following information will be collected from the medical record retrospectively: demographic data (age, gender, ethnicity, height, weight), past medical history, laboratory results, microbiologic data, data on the patients' devices (type of device, data that it was placed, exchanged or removed), treatment and clinical and microbiological outcomes. This will all be collected retrospectively. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | infected ventricular shunt |
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| Condition ICMJE | Ventricular Shunt Infection | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| 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 | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00470132 | ||||
| Other Study ID Numbers ICMJE | PRO07040262 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Pittsburgh | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | August 2012 | ||||
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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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