- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932853
Association Between Dose Dialysis by Kt and Mortality
July 12, 2016 updated by: Rosa Ramos, NephroCare Spain
Evaluation of the Association of Dialysis Dose Obtained by Kt and Mortality in Hemodialysis Patients
The aim of this study is to assess whether patients receiving current recommendations of an adequate dialysis dose by Kt adjusted for body surface area improved survival at 24 months compared to those who do not get it, as well as assess whether patients receiving a dose greater obtain more benefit.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
6129
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
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Madrid, Spain, 28042
- NephroCare Spain
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study subjects:
Patients> 18 years in hemodialysis treatment at any FMC center of Spain that meet the inclusion criteria.
Data will be collected according to clinical practice and patients will be categorized according to their dose of Kt, along the two years of the study. Will seek the association of dialysis dose with mortality and hospitalization
Description
Inclusion Criteria:
- > 18 years old
- > six months on hemodialysis
- Receiving 3 sessions of dialysis per week
- Having 5 or more valid measures of Kt during the month
Exclusion Criteria:
- active chronic inflammatory diseases
- Liver cirrhosis
- Neoplasms
- Chronic immunosuppression or use of anti-inflammatory
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 |
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Hemodialysis patients
Patients > 18y hemodialysis for at least 6 months at any center of Spain Fresenius Medical Care (FMC) meeting the inclusion criteria.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: two years
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two years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospitalization
Time Frame: two years
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two years
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality and hospitalization cause
Time Frame: two years
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francesc Maduell, MD, Ph, Servei Nefrologia, ICNU, Hospital Clínic.
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
October 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
August 27, 2013
First Submitted That Met QC Criteria
August 27, 2013
First Posted (Estimate)
August 30, 2013
Study Record Updates
Last Update Posted (Estimate)
July 13, 2016
Last Update Submitted That Met QC Criteria
July 12, 2016
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QM-RR-02
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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