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Completed

NCT Number: NCT01285726

Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)

The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.

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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

Klinikum Wels, Wels, Austria

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About this study

Achieving optimal fluid balance remains a major clinical challenge in peritoneal dialysis (PD) patients. With the recent development of a new bioimpedance spectroscopy (BIS) device, the BCM-Body Composition Monitor (BCM), it is now possible to quantify deviations of hydration status and to define target weight directly.

It has been observed that more than 50% of the PD patients are overhydrated, as compared to the healthy population. This overhydration seems to be associated with modifiable practice-related factors, such as correct PD prescription according to membrane transport status, and dietary fluid intake.

The aim of this study is to assess the hydration status of incident PD patients, and diagnose the underlying reasons for incorrect fluid status. In addition, changes in fluid status, residual renal function and nutritional status, over a follow-up period of up to four years will be registered.

The investigators assume that the use of the BCM-Body Composition Monitor (BCM) provides quantitative measurement of hydration status and thereby supports physicians in identifying patients who are not euvolaemic. Hence, the BCM allows an improved management of underlying causes of non-euvolaemic hydration state and appropriate monitoring of fluid status.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Incident patients directly before start of peritoneal dialysis
  • Patients in whom routine measurement of body composition monitoring is performed

Exclusion criteria

  • Patients treated with HD before start of PD
  • Patients in whom body composition monitoring cannot be performed

Treatment and study plan

Non-Interventional Study

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 over a period of four years

    Assessed via body composition measurements (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW)) (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW))

Secondary outcomes

  1. Residual renal function

    Time frame: Every three months over a period of four years

  2. Peritoneal transport status

    Time frame: Every three months over a period of four years

  3. Time to change to haemodialysis

    Time frame: Four years

  4. Changes in PD prescription

    Time frame: Four years

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Official study title

Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)

Acronym: IPOD-PD

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 28, 2011
Registry last updated
May 2, 2016

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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