Transfer and Ultrafiltration In Peritoneal Dialysis

End-stage Renal Disease Clinical Trial

— TULIPE  

Official title:

Transfer and Ultrafiltration In Peritoneal Dialysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02474719
• Other study ID #: TULIPE
• Status: Terminated
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 18, 2018

Study information

• Verified date: February 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Besançon University Hospital, Nephrology Department	Besançon	Franche-Comté

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins)		In a maximum of 72 hours after collection