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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT01285726
First received: January 26, 2011
Last updated: August 13, 2013
Last verified: August 2013

January 26, 2011
August 13, 2013
January 2011
December 2015   (final data collection date for primary outcome measure)
Hydration status [ Time Frame: Every three months over a period of four years ] [ Designated as safety issue: No ]
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))
Same as current
Complete list of historical versions of study NCT01285726 on ClinicalTrials.gov Archive Site
  • Residual renal function [ Time Frame: Every three months over a period of four years ] [ Designated as safety issue: No ]
  • Peritoneal transport status [ Time Frame: Every three months over a period of four years ] [ Designated as safety issue: No ]
  • Time to change to haemodialysis [ Time Frame: Four years ] [ Designated as safety issue: No ]
  • Changes in PD prescription [ Time Frame: Four years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)
Initiative for Patient Outcomes in 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adult patients with chronic kidney disease (CKD) starting renal replacement therapy on APD or CAPD

Chronic Renal Failure
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.
Other Name: Observational study
ESRD patients treated with PD
Intervention: Other: Non-interventional study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Bosnia and Herzegovina,   Brazil,   Croatia,   Cuba,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   Norway,   Portugal,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom,   Venezuela
 
NCT01285726
BCM-PD-02-INT
No
Fresenius Medical Care Deutschland GmbH
Fresenius Medical Care Deutschland GmbH
Not Provided
Study Chair: Claudio Ronco, Prof Ospedale San Bartolo
Study Chair: Wim Van Biesen, Prof Ghent University Hospital
Study Chair: Christian Verger, Dr Centre Hospitalier René Dubos
Study Chair: John Williams, Prof The University of New South Wales
Fresenius Medical Care Deutschland GmbH
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP