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Transfer and Ultrafiltration In Peritoneal Dialysis (TULIPE)

Primary Purpose

End-stage Renal Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
comparison of two regimens in peritoneal dialysis
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End-stage Renal Disease focused on measuring nephrology, extra-renal purification, peritoneal dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Besançon University Hospital, Nephrology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

conventional scheme followed by alternate schem

alternate scheme followed by conventional scheme

Arm 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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 3, 2015
Last Updated
August 5, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02474719
Brief Title
Transfer and Ultrafiltration In Peritoneal Dialysis
Acronym
TULIPE
Official Title
Transfer and Ultrafiltration In Peritoneal Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
few eligible patients, dialysate drainage problem, measurement bias : not all currently marketed laboratory instruments are able to dose peritoneal dialysate
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 18, 2018 (Actual)
Study Completion Date
July 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
nephrology, extra-renal purification, peritoneal dialysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional scheme followed by alternate schem
Arm Type
Experimental
Arm 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.
Arm Title
alternate scheme followed by conventional scheme
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
comparison of two regimens in peritoneal dialysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins)
Time Frame
In a maximum of 72 hours after collection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile Courivaud, MCU/PH
Organizational Affiliation
Besançon University Hospital, nephrology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Besançon University Hospital, Nephrology Department
City
Besançon
State/Province
Franche-Comté
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

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Transfer and Ultrafiltration In Peritoneal Dialysis

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