Events Before Death

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329055
• Other study ID #: 10-119
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: April 4, 2011
• Start date: January 2000
• Est. completion date: May 2010

Study information

• Verified date: April 2011
• Source: Renal Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50000
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

• Hemodialysis vintage 2+ months

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Locations

Country	Name	City	State
United States	Renal Research Institute	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Renal Research Institute	Fresenius Medical Care North America, Maastricht University, Medical University Innsbruck, University of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Date of death	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	No
Secondary	Hospitalizations		January 2000 - May 2010	No