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Events Before Death

This study has been completed.
Sponsor:
Collaborators:
Fresenius Medical Care North America
Maastricht University
University of California
Medical University Innsbruck
Information provided by:
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT01329055
First received: April 4, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Renal Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Hospitalizations [ Time Frame: January 2000 - May 2010 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hemodialysis patients

Criteria

Inclusion Criteria:

  • Hemodialysis vintage 2+ months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter Kotanko MD, Renal Research Institute
ClinicalTrials.gov Identifier: NCT01329055     History of Changes
Other Study ID Numbers: 10-119
Study First Received: April 4, 2011
Last Updated: April 4, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013