Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006506

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

IPOD-PD

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006506
  •   2015/01/15
  •   2011/01/26
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01285726  (ClinicalTrials.gov)
  •   BCM-PD-02-INT  (Fresenius Medical Care Deutschland GmbH)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Chronic Renal Failure
  •   N18 -  Chronic kidney disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Other: Non-interventional study
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- 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))

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Residual renal function; time frame: Every three months over a period of four years
- Peritoneal transport status; time frame: Every three months over a period of four years
- Time to change to haemodialysis; time frame: Four years
- Changes in PD prescription; time frame: Four years

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   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, Bolivarian Republic of
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2011/01/31
  •   300
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Incident patients directly before start of peritoneal dialysis

- Patients in whom routine measurement of body composition monitoring is performed

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Patients treated with HD before start of PD

- Patients in whom body composition monitoring cannot be performed

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Fresenius Medical Care Deutschland GmbH
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Ospedale San Bartolo
    • Claudio Ronco, Prof 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Ospedale San Bartolo
    • Claudio Ronco, Prof 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.