Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability

Study Overview
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Brief Summary
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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.

Official Title
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Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability

Conditions
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Fluid Overload, Peritoneal Hyperpermeability, Peritoneal Dialysis, Chronic Kidney Disease

Intervention / Treatment
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* Biological: modified Peritoneal Equilibration test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br> | Biological: modified Peritoneal Equilibration test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 7 | 
| 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 | Day 45 | 
| 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. | Day 45 | 
| 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 | Day 365 | 
| 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. | Day 365 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid overload, Hydratation statud, Peritoneal hypepermeability, Peritoneal dialysis, Impedancemetry