Clinical trial NCT03970018: ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure?
Official title: ADPKD Patients and Peritoneal Dialysis: Creation and Validation of Predictive Score for Peritoneal Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Autosomal dominant polycystic kidney disease
peritoneal dialysis
peritoneal pressure
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Autosomal dominant polycystic kidney disease (ADPKD) patients starting peritoneal dialysis for end stage renal failure

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Creation of a predictive score of intra-peritoneal pressure
timeFrame: Day 0
measure: Validation of a predictive score of intraperitoneal pressure
timeFrame: Day 0
Secondary outcomes:
measure: Global survival
timeFrame: 12 months
measure: Technical survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: