NCT02474719TerminatedNot Applicable
Transfer and Ultrafiltration In Peritoneal Dialysis
Centre Hospitalier Universitaire de Besancon2 sites in 1 country17 target enrollmentStarted: January 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins)
Study Overview
Brief Summary
The aim of this study is to demonstrate the efficiency of an adapted and "alternate" peritoneal dialysis scheme in terms of sodium extraction and purification compared to an adapted conventional peritoneal dialysis scheme.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients hospitalized in the Nephrology department of the Besançon University Hospital
- •Patients treated by continuous ambulatory peritoneal dialysis or ambulatory peritoneal dialysis for at least 6 months
- •Absence of hospitalization caused by an infection in the month prior to inclusion
- •Patients with a ratio (D / P) of the concentration of creatinine in the blood and dialysate between 0.5 and 0.8 on a checkup of less than 1 year.
- •No contraindication to the use of hypertonic bag
- •Signature of informed consent for participation indicating that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study
- •Affiliation to a French social security system or beneficiary
Exclusion Criteria
- •Legal incapacity or limited legal capacity
- •Patients unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
- •Patients without health insurance
- •Pregnant women
- •Patient being in the exclusion period from another study or planned by the "national register of volunteers"
- •Hospitalization caused by an infection in the month prior to inclusion
- •Patients with a peritoneal dialysis catheter dysfunction
Outcomes
Primary Outcomes
Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins)
Time Frame: In a maximum of 72 hours after collection
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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