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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03322410
• Other study ID #: PA17003
• Status: Not yet recruiting
• Phase: N/A
• First received: October 23, 2017
• Last updated: October 23, 2017
• Start date: November 1, 2017
• Est. completion date: November 1, 2020

Study information

• Verified date: October 2017
• Source: CHU de Reims
• Contact: Fatouma TOURE
• Phone: 0326787638
• Email: ftoure[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Fluid Overload
• Kidney Diseases
• Peritoneal Dialysis
• Peritoneal Hyperpermeability
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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