ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure?
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Interventions
- Other: Intra-peritoneal pressure
- Registration Number
- NCT03970018
- Lead Sponsor
- CHU de Reims
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Autosomal dominant polycystic kidney disease Intra-peritoneal pressure Autosomal dominant polycystic kidney disease (ADPKD) patients starting peritoneal dialysis for end stage renal failure will be included in this study.
- Primary Outcome Measures
Name Time Method Validation of a predictive score of intraperitoneal pressure Day 0 Measurment and calculation of intraperitoneal pressure
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.
- Secondary Outcome Measures
Name Time Method Technical survival 12 months Data regarding technical survival will be recorded 12 months after the beginning of peritoneal dialysis.
Global survival 12 months Data regarding global survival will be recorded 12 months after the beginning of peritoneal dialysis.
Trial Locations
- Locations (1)
Damien JOLLY
🇫🇷Reims, France