Events Before Death

April 4, 2011 updated by: Renal Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10128
        • Renal Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemodialysis patients

Description

Inclusion Criteria:

  • Hemodialysis vintage 2+ months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hemodialysis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years and 5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospitalizations
Time Frame: January 2000 - May 2010
January 2000 - May 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renal Research Institute

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 4, 2011

First Posted (Estimate)

April 5, 2011

Study Record Updates

Last Update Posted (Estimate)

April 5, 2011

Last Update Submitted That Met QC Criteria

April 4, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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