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

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ClinicalTrials.gov Identifier: NCT01285726
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Renal Failure Other: Non-interventional study

Detailed Description:

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.

Study Design

Study Type : Observational
Actual Enrollment : 1092 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)
Study Start Date : January 2011
Primary Completion Date : December 2015
Study Completion Date : December 2015
Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with chronic kidney disease (CKD) starting renal replacement therapy on APD or CAPD

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
Contacts and Locations

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): NCT01285726

  Show 134 Study Locations
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Study Chair: Claudio Ronco, Prof Ospedale San Bartolo
Study Chair: Wim Van Biesen, Prof University Hospital, Ghent
Study Chair: Christian Verger, Dr French Language PD Registry (RDPLF)
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT01285726     History of Changes
Other Study ID Numbers: BCM-PD-02-INT
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016

Keywords provided by Fresenius Medical Care Deutschland GmbH:
Peritoneal dialysis
Hydration status
Residual renal function
Bioimpedance spectroscopy
Body composition monitor

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic