Transfer and Ultrafiltration In Peritoneal Dialysis

NCT02474719 | Terminated

• 1 other identifier: TULIPE
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

nephrology; extra-renal purification; peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins)

  In a maximum of 72 hours after collection

Study Arms (2)

conventional scheme followed by alternate schem

EXPERIMENTAL

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.

Other: comparison of two regimens in peritoneal dialysis

alternate scheme followed by conventional scheme

EXPERIMENTAL

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).

Other: comparison of two regimens in peritoneal dialysis

Interventions

comparison of two regimens in peritoneal dialysis 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; conventional scheme followed by alternate schem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Patients with a peritoneal dialysis catheter dysfunction

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Besançon University Hospital, Nephrology Department

Besançon, Franche-Comté, 25000, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Peritoneal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Cécile Courivaud, MCU/PH

  Besançon University Hospital, nephrology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 18, 2015
• Study Start: January 1, 2015
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: August 7, 2019

Record last verified: 2017-02

Locations

FR (1)