Events Before Death
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 4, 2011 | ||||
| Last Updated Date | April 4, 2011 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Date of death [ Time Frame: 10 years and 5 months ] [ Designated as safety issue: No ] The main purpose of the study is developing an alert system that will help dialysis providers recognize patients who are at increased risk of death (or hospitalization). This alert system will be developed and can be utilized in patients treated all over the world. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Hospitalizations [ Time Frame: January 2000 - May 2010 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Events Before Death | ||||
| Official Title ICMJE | International Comparison of Evolution of Clinical and Laboratory Parameters in Chronic Hemodialysis Patients | ||||
| Brief Summary | Previous studies of the patients treated in RRI clinics suggest that hemodialysis patients undergo a certain consistent predictable pattern at the initiation of dialysis and before death. This pattern can be described as a group of patterns of patients' biological markers over a few months after starting dialysis and several months prior to death. Additional patterns can be observed that occur with changes in seasons or time of day. The aim of this study is to compare these patterns in patients treated in FMC-Asia, FMC-Europe, FMC-South America, and RRI-US populations. Noting that patterns in patient parameters are similar across continents, climates, and geographic variations only further accentuates the importance in the models that can predict patients' survival and provide an opportunity for timely intervention. |
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| Detailed Description | Not Provided | ||||
| 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 | Non-Probability Sample | ||||
| Study Population | Hemodialysis patients |
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| Condition ICMJE | End Stage Renal Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Hemodialysis patients | ||||
| 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 | 50000 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 88 Years | ||||
| 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 | NCT01329055 | ||||
| Other Study ID Numbers ICMJE | 10-119 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Peter Kotanko MD, Renal Research Institute | ||||
| Study Sponsor ICMJE | Renal Research Institute | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Renal Research Institute | ||||
| Verification Date | April 2011 | ||||
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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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