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OpenTrials
Completed

NCT Number: NCT01329055

Events Before Death

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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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renal Research Institute

New York, 10128, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis vintage 2+ months

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Hospitalizations

    Time frame: January 2000 - May 2010

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Sponsors and collaborators

Lead sponsor

Renal Research Institute

Other

Collaborators

  • Fresenius Medical Care North America
  • Maastricht University
  • Medical University Innsbruck
  • University of California

Registry information

Official study title

International Comparison of Evolution of Clinical and Laboratory Parameters in Chronic Hemodialysis Patients

Important dates

Study start
2000
Primary completion
2010
Study completion
2010
First posted
Apr 5, 2011
Registry last updated
Apr 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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