PDP-ADPKD: ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure?

Sponsor

CHU de Reims (Other)

Overall Status

Completed

CT.gov ID

NCT03970018

Collaborator

(none)

210

Enrollment

Location

Actual Duration (Months)

23.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Autosomal dominant polycystic kidney disease (ADPKD) is first genetic kidney disease and fourth etiology of end stage renal disease in the world. Peritoneal dialysis is underuse in this population. Indeed in this pathology, behind big kidneys and big liver, a hyper pressure is feared with technical failure. The lack of abdominal space could generate increase of peritoneal pressure. Hyper pressure is already known to be a risk factor of technical failure and over mortality in peritoneal dialysis patients (all nephropathies included). It depends on body mass index and body surface modulating injected volume for each patient. Anticipate peritoneal pressure in this population ADPKD could be an important information for distinguish those who can use peritoneal dialysis without fear and those at risk of technical failure.

The primary objective is to create and validate prediction score for intra-peritoneal pressure, in peritoneal dialysis for ADPKD patients thanks to clinical and radiological values.

The secondary objectives are to study the association between intra-peritoneal pressure and patient's outcome (global survival and technical survival).

Retrospective, multicentric, national, cohort study will be performed. For the first step (score creation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2010 and 31/12/2015 with tomodensitometry between one year before beginning and one year after were included.

For the second step (score validation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2016 and 31/12/2017 with tomodensitometry between one year before beginning and one year after were included.

Condition or Disease	Intervention/Treatment	Phase
Autosomal Dominant Polycystic Kidney Disease	Other: Intra-peritoneal pressure

Detailed Description

The primary objective is to create and validate prediction score for intra-peritoneal pressure, in peritoneal dialysis for ADPKD patients thanks to clinical and radiological values.

The secondary objectives are to study the association between intra-peritoneal pressure and patient's outcome (global survival and technical survival).

Data regarding organ volume and clinical data wich can influence pressure and patient's outcome (global survival and technical survival) will be recorded.

A bivariate analysis will be performed to study the association between intra-peritoneal pressure and clinical data. A multivariate analysis by multiple linear regressions will be performed to create the score. Survival analysis by log rank test and cox regression model will be performed for global survival and technical survival.

Study Design

Study Type:

Observational

Actual Enrollment :

210 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

ADPKD Patients and Peritoneal Dialysis: Creation and Validation of Predictive Score for Peritoneal Pressure

Actual Study Start Date :

Dec 1, 2017

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease (ADPKD) patients starting peritoneal dialysis for end stage renal failure will be included in this study.	Other: Intra-peritoneal pressure Measurement of intra-peritoneal pressure

Arm

Intervention/Treatment

Autosomal dominant polycystic kidney disease

Autosomal dominant polycystic kidney disease (ADPKD) patients starting peritoneal dialysis for end stage renal failure will be included in this study.

Other: Intra-peritoneal pressure

Measurement of intra-peritoneal pressure

Outcome Measures

Primary Outcome Measures

Creation of a predictive score of intra-peritoneal pressure [Day 0]
Data regarding organ volume and clinical data wich can influence intra-peritoneal pressure will be recorded. A bivariate analysis will be performed to study the association between intra-peritoneal pressure and clinical data. A multivariate analysis by multiple linear regressions will be performed.
Validation of a predictive score of intraperitoneal pressure [Day 0]
Measurment and calculation of intraperitoneal pressure

Secondary Outcome Measures

Global survival [12 months]
Data regarding global survival will be recorded 12 months after the beginning of peritoneal dialysis.
Technical survival [12 months]
Data regarding technical survival will be recorded 12 months after the beginning of peritoneal dialysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Major ADPKD patients starting peritoneal dialysis for end stage renal disease between 2010 January 1st and 2015 December 31
Must have an abdominal tomodensitometry in 2 years around start (between 1 year before and 1 year after)
Must have an intraperitoneal pressure measurement in the first year of peritoneal dialysis.
Major ADPKD patients starting peritoneal dialysis for end stage renal disease between 2015 January 1st and 2017 December 31