Transfer and Ultrafiltration In Peritoneal Dialysis

NCT ID: NCT02474719

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-07-18

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.

Conditions

End-stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

conventional scheme followed by alternate schem

The first day of the study, patients receive an adapted conventional peritoneal dialysis scheme: 2 cycles of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 2 cycles of purification (stasis: 110 mn ; volume 1200cc/m²).

The second day, patients receive an adapted and alternate scheme: 1 cycle of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 1 cycle of purification (stasis: 110 mn ; volume 1200cc/m²), the two cycles being repeated once.

Group Type: EXPERIMENTAL

comparison of two regimens in peritoneal dialysis

Intervention Type: OTHER

Dialysate samples (8 by scheme, volume of 10 mL) are collected at each cycle (one at the beginning and one at the end of the cycle). A blood sample (5 mL) is collected at the beginning of the second scheme and a 24-hour urine sample at the end of the second scheme.

alternate scheme followed by conventional scheme

The first day of the study, patients receive an adapted and alternate peritoneal dialysis scheme: 1 cycle of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 1 cycle of purification (stasis: 110 mn ; volume 1200cc/m²), the two cycles being repeated once.

The second day, patients receive an adapted conventional scheme: 2 cycles of ultrafiltration (stasis: 35 mn ; volume: 650cc/m²) and 2 cycles of purification (stasis: 110 mn ; volume 1200cc/m²).

Group Type: EXPERIMENTAL

comparison of two regimens in peritoneal dialysis

Intervention Type: OTHER

Dialysate samples (8 by scheme, volume of 10 mL) are collected at each cycle (one at the beginning and one at the end of the cycle). A blood sample (5 mL) is collected at the beginning of the second scheme and a 24-hour urine sample at the end of the second scheme.

Interventions

comparison of two regimens in peritoneal dialysis

Dialysate samples (8 by scheme, volume of 10 mL) are collected at each cycle (one at the beginning and one at the end of the cycle). A blood sample (5 mL) is collected at the beginning of the second scheme and a 24-hour urine sample at the end of the second scheme.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cécile Courivaud, MCU/PH

Role: PRINCIPAL_INVESTIGATOR

Besançon University Hospital, nephrology department

Locations

Besançon University Hospital, Nephrology Department

Besançon, Franche-Comté, France

Countries

France

Other Identifiers

TULIPE

Identifier Type: -

Identifier Source: org_study_id