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PD-Improved Dialysis Efficiency With Adapted APD (PD-IDEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470598
Recruitment Status : Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH

Brief Summary:
The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or improvement of the hydration status of more than 250 PD patients, and to observe the tolerability of the therapy over a long period.

Condition or disease Intervention/treatment
Chronic Renal Failure Other: Treatment with Adapted Automated Peritoneal Dialysis (aAPD)

Detailed Description:

In some studies it has been observed that the use of a combination of short dwell/small volume and long dwell/large volume can improve the effectiveness of APD. However, these studies have been performed in a small number of patients during a short observation period.

The aim of this study is to assess the hydration status of PD patients treated with aAPD and observe its development during one year using the BCM-Body Composition Monitor (BCM), a bioimpedance spectroscopy (BIS) device. In addition, it is intended to observe the variability of aAPD prescriptions and their influence on the hydration status of the patients.

This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PD-Improved Dialysis Efficiency With Adapted APD - PD-IDEA
Study Start Date : March 2015
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis


Intervention Details:
  • Other: Treatment with Adapted Automated Peritoneal Dialysis (aAPD)
    This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists


Primary Outcome Measures :
  1. Hydration status [ Time Frame: Every three months during one year ]
    Assessed via body composition measurements


Secondary Outcome Measures :
  1. Residual renal function [ Time Frame: Every three months during one year ]
  2. Changes in prescription [ Time Frame: Every three months during one year ]
  3. Achievement of adequate solute removal [ Time Frame: Every three months during one year ]
  4. Therapy tolerability [ Time Frame: Every three months during one year ]

Other Outcome Measures:
  1. Change of therapy modality [ Time Frame: Every three months during one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic kidney disease (CKD) being treated or starting renal replacement therapy with aAPD
Criteria

Inclusion Criteria:

  • CKD patients with indication for renal replacement therapy
  • Patient treated or to be treated with aAPD
  • Fluid status regularly monitored with BCM

Exclusion Criteria:

  • Patients who have any condition prohibiting the use of BCM like patients with major amputations (e.g. lower leg)
  • Participation in an interventional study which could have an effect on the study objectives hydration status and dialysis adequacy (e.g. studies on PD solutions, studies on diuretics)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470598


Locations
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Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
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Study Director: Michel Fischbach, Prof. University Hospital Hautepierre
Study Director: Manel Vera, Dr. Hospital Clinic i Provinvial de Barcelona
Study Director: Emilio Galli, Dr. Ospedale "Treviglio-Caravaggio" di Treviglio
Study Director: Cecile Courivaud, Dr. University Hospotal Besancon
Study Director: Virpi Rauta, Dr. Helsinki Univerity Hospital
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Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT02470598    
Other Study ID Numbers: PD-aAPD-01-INT
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Keywords provided by Fresenius Medical Care Deutschland GmbH:
Automated Peritoneal Dialysis
Adapted APD (aAPD)
Hydration status
Residual Renal Function
Ultrafiltration
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic