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

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

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.

Study Overview

• Status: Completed
• Conditions: Autosomal Dominant Polycystic Kidney Disease
• Intervention / Treatment: Other: Intra-peritoneal pressure

Detailed Description

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 will be 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 will be included.

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 Type: Observational
• Enrollment (Actual): 210

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

• Sampling Method: Non-Probability Sample

Study Population

Autosomal dominant polycystic kidney disease (ADPKD) patients starting peritoneal dialysis for end stage renal failure

Description

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

Non-inclusion criteria:

• Lack of tomodensitometry or intraperitoneal pressure.
• History of nephrectomy or arterioembolism

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of a predictive score of intra-peritoneal pressure	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.	Day 0
Validation of a predictive score of intraperitoneal pressure	Measurment and calculation of intraperitoneal pressure	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global survival	Data regarding global survival will be recorded 12 months after the beginning of peritoneal dialysis.	12 months
Technical survival	Data regarding technical survival will be recorded 12 months after the beginning of peritoneal dialysis.	12 months

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: peritoneal dialysis; Autosomal dominant polycystic kidney disease; peritoneal pressure
• Additional Relevant MeSH Terms: Urologic Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Abnormalities, Multiple; Kidney Diseases, Cystic; Ciliopathies; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
• Other Study ID Numbers: PA18042

Drug and device information, study documents

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