End-stage Renal DiseaseTULIPENCT02474719
Transfer and Ultrafiltration In Peritoneal Dialysis
A study testing comparison of two regimens in peritoneal dialysis in people with End-stage Renal Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- comparison of two regimens in peritoneal dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to 18 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Besançon University Hospital, Nephrology Department
Besançon, Franche-Comté, 25000
About this study
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
- Being tested
- comparison of two regimens in peritoneal dialysis
- Keywords
- nephrology, extra-renal purification, peritoneal dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of two regimens in peritoneal dialysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: comparison of two regimens in peritoneal dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins)
Measured: In a maximum of 72 hours after collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJan 2015
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Why it stopped: few eligible patients, dialysate drainage problem, measurement bias : not all currently marketed laboratory instruments are able to dose peritoneal dialysate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Courivaud, MCU/PH, Principal investigator, Besançon University Hospital, nephrology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474719
- Sponsor's protocol ID
- TULIPE
- Acronym
- TULIPE
- Status last verified
- Feb 2017
- First submitted
- 3 Jun 2015
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer and Ultrafiltration In Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT02474719
- Acronym / sponsor ID
- TULIPE / TULIPE
- Conditions
- End-stage Renal Disease
- Keywords
- nephrology, extra-renal purification, peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: few eligible patients, dialysate drainage problem, measurement bias : not all currently marketed laboratory instruments are able to dose peritoneal dialysate
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional scheme followed by alternate schem | Experimental | Other: comparison of two regimens in peritoneal dialysisThe 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. |
| alternate scheme followed by conventional scheme | Experimental | Other: comparison of two regimens in peritoneal dialysisThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison of two regimens in peritoneal dialysisDialysate 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. | Other | alternate scheme followed by conventional scheme, conventional scheme followed by alternate schem |
Primary outcome
Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins)
Time frame: In a maximum of 72 hours after collection
Results and safety
The study was stopped early (reason given: few eligible patients, dialysate drainage problem, measurement bias : not all currently marketed laboratory instruments are able to dose peritoneal dialysate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
Related trials for End-stage Renal Disease
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Courivaud, MCU/PH principal investigator
Besançon University Hospital, nephrology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparison of two regimens in peritoneal dialysis in people with End-stage Renal Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: few eligible patients, dialysate drainage problem, measurement bias : not all currently marketed laboratory instruments are able to dose peritoneal dialysate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-dialytic concentrations of different electrolytes (sodium, phosphorus, urea, creatinine, glucose and proteins) (time frame: In a maximum of 72 hours after collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.