Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)
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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) |
- 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))
- 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 |
| 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 |
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| Contact: Tatiana De los Rios | +4961726092362 | tatiana.de-los-rios@fmc-ag.com |
Show 136 Study Locations| 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 |
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 21, 2012 |
| 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:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013