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Completed

NCT Number: NCT02470598

PD-Improved Dialysis Efficiency With Adapted APD

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.

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty Hospital Brno-Bohunice, Brno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Treatment with Adapted Automated Peritoneal Dialysis (aAPD)

Other

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

Primary outcomes

  1. Hydration status

    Time frame: Every three months during one year

    Assessed via body composition measurements

Secondary outcomes

  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 outcomes

  1. Change of therapy modality

    Time frame: Every three months during one year

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Official study title

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

Acronym: PD-IDEA

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2015
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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