Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
Primary Purpose
Fluid Overload, Peritoneal Hyperpermeability, Peritoneal Dialysis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
modified Peritoneal Equilibration test
Sponsored by
About this trial
This is an interventional other trial for Fluid Overload focused on measuring Fluid overload, Hydratation statud, Peritoneal hypepermeability, Peritoneal dialysis, Impedancemetry
Eligibility Criteria
Inclusion criteria:
- End stage chronic kidney disease
- Ambulatory
- Starting a peritoneal dialysis in one of the participant centers
- Accepting the study protocol
- Age > 18yo
Exclusion criteria:
- Age <18yo
- Protected by the law
Sites / Locations
- Damien JOLLY
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Outcomes
Primary Outcome Measures
Hydratation status
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)
FO < 10th percentile = extracellular dehydration
10th percentile < FO < 90th percentile = extracellular normohydration
FO > 90th percentile = extracellular hyperhydration
Secondary Outcome Measures
Peritoneal permeability
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.
Hydratation status
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)
FO < 10th percentile = extracellular dehydration
10th percentile < FO < 90th percentile = extracellular normohydration
FO > 90th percentile = extracellular hyperhydration
Peritoneal permeability
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.
Hydratation status
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)
FO < 10th percentile = extracellular dehydration
10th percentile < FO < 90th percentile = extracellular normohydration
FO > 90th percentile = extracellular hyperhydration
Peritoneal permeability
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03322410
Brief Title
Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
Official Title
Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing determination of hydratation status in patients with chronic kidney disease treated with peritoneal dialysis (PD). Overhydratation attested by bioimpedance is strongly associated with cardio-vascular morbidity and mortality in patients with PD. Overhydratation might concern more than half of patients at PD initiation, though the underlying mechanism remains unknown.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Overload, Peritoneal Hyperpermeability, Peritoneal Dialysis, Chronic Kidney Disease
Keywords
Fluid overload, Hydratation statud, Peritoneal hypepermeability, Peritoneal dialysis, Impedancemetry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
modified Peritoneal Equilibration test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hydratation status
Description
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)
FO < 10th percentile = extracellular dehydration
10th percentile < FO < 90th percentile = extracellular normohydration
FO > 90th percentile = extracellular hyperhydration
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Peritoneal permeability
Description
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.
Time Frame
Day 7
Title
Hydratation status
Description
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)
FO < 10th percentile = extracellular dehydration
10th percentile < FO < 90th percentile = extracellular normohydration
FO > 90th percentile = extracellular hyperhydration
Time Frame
Day 45
Title
Peritoneal permeability
Description
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.
Time Frame
Day 45
Title
Hydratation status
Description
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)
FO < 10th percentile = extracellular dehydration
10th percentile < FO < 90th percentile = extracellular normohydration
FO > 90th percentile = extracellular hyperhydration
Time Frame
Day 365
Title
Peritoneal permeability
Description
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.
Time Frame
Day 365
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
End stage chronic kidney disease
Ambulatory
Starting a peritoneal dialysis in one of the participant centers
Accepting the study protocol
Age > 18yo
Exclusion criteria:
Age <18yo
Protected by the law
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatouma TOURE
Phone
0326787638
Ext
+33
Email
ftoure@chu-reims.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent DUPONT
Email
vdupont@vhu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatouma TOURE
Email
ftoure@chu-reims.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
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