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
  Purpose

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 Intervention
Chronic Renal Failure
Other: Non-interventional study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care Deutschland GmbH:

Primary Outcome Measures:
  • 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))


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ESRD patients treated with PD 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285726

  Show 135 Study Locations
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
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 University Hospital of Wales
  More Information

No publications provided

Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT01285726     History of Changes
Other Study ID Numbers: BCM-PD-02-INT
Study First Received: January 26, 2011
Last Updated: August 13, 2013
Health Authority: Belgium: Ethics Committee
Bosnia: Federal Ministry of Health
Croatia: Ethics Committee
Finland: Ethics Committee
Estonia: Research Ethics Committee
Germany: Ethics Commission
Greece: Ethics Committee
Italy: Ethics Committee
Latvia: Institutional Review Board
Lithuania: Bioethics Committee
Netherlands: Independent Ethics Committee
Norway: Ethics Committee
Portugal: Health Ethic Committee
Spain: Comité Ético de Investigación Clínica
Sweden: Institutional Review Board
Switzerland: Ethikkommission
Turkey: Ethics Committee
Brazil: Ethics Committee
Cuba: Scientific and Ethics Committee
Venezuela: Ethics Committee
Korea: Institutional Review Board
India: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014