Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
NCT ID: NCT03322410
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-11-01
2020-11-01
Brief Summary
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High peritoneal permeability (HPP) might concern about a third of patients starting a PD, although only a few datas are published on this condition. HPP at initiation of PD is associated with a decrease in both technical and patient survival and might be responsible of ultrafiltration failure. The underlying mechanisms of HPP at initiation of PD also remains unknown.
To our knowledge, the correlation between hydratation status and peritoneal permeability at initiation of peritoneal dialysis remains unknown. Moreover, there is no datas concerning the cinetic evolution of peritoneal permeability; demographic or biologic factors associated with HPP in days and months following PD start.
The aim of the present study is to correlate hydratation status (attested by bioimpedance) and peritoneal permeability at early start of peritoneal dialysis. Thus, we investigated early cinetic of peritoneal permeability at different time point during the first year of peritoneal dialysis and we analyzed the demographical and biological factors associated with HPP and overhydratation during this period.
This study is a prospective, multicentric cohort study. Fourty patients recruited in a two years' period in five centers of nephrology will be included. Hydratation status will be determined with Fluid Overload measurement by bioimpedance technic thanks to BCM system (Fresenius Medical Care®). Peritoneal permeability will be determined by modified Peritoneal Equilibration Test with complete drainage at sixty minutes. Datas will prospectively be collected, including: weight, blood pressure, diuretic posology, diuresis, PD modality, dialysate prescribed.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients
modified Peritoneal Equilibration test
Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky
* " High ": D/P creatinine\>0,8; D/D0 glucose\<0,25
* " High average ": 0,65\< D/P creatinine \<0,8; 0,25\< D/D0 glucose \<0,38
* " Low average ": 0,5\< D/P creatinine \<0,65; 0,39\< D/D0 glucose \< 0,48
* " Low " : D/P creatinine\<0,5 ; D/D0 glucose\>0,49.
Interventions
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modified Peritoneal Equilibration test
Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky
* " High ": D/P creatinine\>0,8; D/D0 glucose\<0,25
* " High average ": 0,65\< D/P creatinine \<0,8; 0,25\< D/D0 glucose \<0,38
* " Low average ": 0,5\< D/P creatinine \<0,65; 0,39\< D/D0 glucose \< 0,48
* " Low " : D/P creatinine\<0,5 ; D/D0 glucose\>0,49.
Eligibility Criteria
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Inclusion Criteria
* Ambulatory
* Starting a peritoneal dialysis in one of the participant centers
* Accepting the study protocol
* Age \> 18yo
Exclusion Criteria
* Protected by the law
18 Years
ALL
No
Sponsors
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CHU de Reims
OTHER
Responsible Party
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Locations
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Damien JOLLY
Reims, , France
Countries
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Central Contacts
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Facility Contacts
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Fatouma TOURE
Role: primary
Other Identifiers
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PA17003
Identifier Type: -
Identifier Source: org_study_id