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

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.

Study Overview

• Status: Unknown
• Conditions: Peritoneal Dialysis; Chronic Kidney Disease; Fluid Overload; Peritoneal Hyperpermeability
• Intervention / Treatment: Biological: modified Peritoneal Equilibration test

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Reims, France
    • Damien JOLLY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Patients

Biological: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2017
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (ACTUAL): October 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Fluid overload; Peritoneal dialysis; Impedancemetry; Hydratation statud; Peritoneal hypepermeability
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: PA17003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No