ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure?

NCT03970018 | Completed

• 1 other identifier: PA18042
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Autosomal dominant polycystic kidney disease; peritoneal dialysis; peritoneal pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Global survival

  12 months

• Technical survival

  12 months

Study Arms (1)

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

Interventions

Intra-peritoneal pressure OTHER

Measurement of intra-peritoneal pressure

Autosomal dominant polycystic kidney disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: May 31, 2019
• Study Start: December 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 31, 2019

Record last verified: 2019-05

Locations

FR (1)