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

  • Spain
      • Madrid, Spain, 28042
        • NephroCare Spain

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
Hemodialysis patients
Patients > 18y hemodialysis for at least 6 months at any center of Spain Fresenius Medical Care (FMC) meeting the inclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospitalization
Time Frame: two years
two years

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

NephroCare Spain

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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