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Events Before Death

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329055
First Posted: April 5, 2011
Last Update Posted: April 5, 2011
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.
Collaborators:
Fresenius Medical Care North America
Maastricht University
University of California
Medical University Innsbruck
Information provided by:
Renal Research Institute
  Purpose
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.

Condition
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: International Comparison of Evolution of Clinical and Laboratory Parameters in Chronic Hemodialysis Patients

Further study details as provided by Renal Research Institute:

Primary Outcome Measures:
  • Date of death [ Time Frame: 10 years and 5 months ]
    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.


Secondary Outcome Measures:
  • Hospitalizations [ Time Frame: January 2000 - May 2010 ]

Enrollment: 50000
Study Start Date: January 2000
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemodialysis patients

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hemodialysis patients
Criteria

Inclusion Criteria:

  • Hemodialysis vintage 2+ months
  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): NCT01329055


Locations
United States, New York
Renal Research Institute
New York, New York, United States, 10128
Sponsors and Collaborators
Renal Research Institute
Fresenius Medical Care North America
Maastricht University
University of California
Medical University Innsbruck
Investigators
Principal Investigator: Peter Kotanko, MD Renal Research Institute
  More Information

Responsible Party: Peter Kotanko MD, Renal Research Institute
ClinicalTrials.gov Identifier: NCT01329055     History of Changes
Other Study ID Numbers: 10-119
First Submitted: April 4, 2011
First Posted: April 5, 2011
Last Update Posted: April 5, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases