Transfer and Ultrafiltration In Peritoneal Dialysis (TULIPE)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Franche-Comté
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Besançon, Franche-Comté, Frankreich, 25000
- Besançon University Hospital, Nephrology Department
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: conventional scheme followed by alternate schem
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. |
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.
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Experimental: alternate scheme followed by conventional scheme
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). |
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins)
Zeitfenster: In a maximum of 72 hours after collection
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In a maximum of 72 hours after collection
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Cécile Courivaud, MCU/PH, Besançon University Hospital, Nephrology Department
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- TULIPE
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