Transfer and Ultrafiltration In Peritoneal Dialysis (TULIPE)

Centre Hospitalier Universitaire de Besancon

Status: Terminated

Conditions: End-stage Renal Disease

Treatments: Other: comparison of two regimens in peritoneal dialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02474719

TULIPE

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

conventional scheme followed by alternate schem

Experimental group

Description:

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.

Treatment:

Other: comparison of two regimens in peritoneal dialysis

alternate scheme followed by conventional scheme

Experimental group

Description:

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).

Treatment:

Other: comparison of two regimens in peritoneal dialysis