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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02474719
Date of registration: 03/06/2015
Prospective Registration: No
Primary sponsor: Centre Hospitalier Universitaire de Besancon
Public title: Transfer and Ultrafiltration In Peritoneal Dialysis TULIPE
Scientific title: Transfer and Ultrafiltration In Peritoneal Dialysis
Date of first enrolment: January 2015
Target sample size: 17
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02474719
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Cécile Courivaud, MCU/PH
Address: 
Telephone:
Email:
Affiliation:  Besançon University Hospital, nephrology department
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
End-stage Renal Disease
Intervention(s)
Other: comparison of two regimens in peritoneal dialysis
Primary Outcome(s)
Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins) [Time Frame: In a maximum of 72 hours after collection]
Secondary Outcome(s)
Secondary ID(s)
TULIPE
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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