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

Not Applicable

• Conditions: Peritoneal Hyperpermeability; Peritoneal Dialysis; Chronic Kidney Disease; Fluid Overload
• Interventions: Biological: modified Peritoneal Equilibration test

• Registration Number: NCT03322410
• Lead Sponsor: CHU de Reims

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Last Update Submitted: 2017-10-23
• Study First Posted: 2017-10-26
• Last Update Posted: 2017-10-26
• Study Start: 2017-11-01
• Primary Completion: 2019-11-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	modified Peritoneal Equilibration test	-

Primary Outcome Measures

Name	Time	Method
Hydratation status	Day 7	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

Name	Time	Method
Peritoneal permeability	Day 365	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	Day 365	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

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France