Fluid OverloadNCT03322410
Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
A study testing modified Peritoneal Equilibration test in people with Fluid Overload and Peritoneal Hyperpermeability, run by CHU de Reims at 1 site in France.
Trial summary
Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing determination of hydratation status in patients with chronic kidney disease treated with peritoneal dialysis (PD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, Peritoneal Hyperpermeability, Peritoneal Dialysis
- What is being tested?
- modified Peritoneal Equilibration test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2017to 1 Nov 2020
- 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
- End stage chronic kidney disease
- Ambulatory
- Starting a peritoneal dialysis in one of the participant centers
- Accepting the study protocol
- Age > 18yo
Who cannot join
- Age <18yo
- Protected by the law
Trial locations and contacts
1 site in 1 country.
Vincent DUPONT contact
About this study
Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing determination of hydratation status in patients with chronic kidney disease treated with peritoneal dialysis (PD). Overhydratation attested by bioimpedance is strongly associated with cardio-vascular morbidity and mortality in patients with PD. Overhydratation might concern more than half of patients at PD initiation, though the underlying mechanism remains unknown.
High peritoneal permeability (HPP) might concern about a third of patients starting a PD, although only a few datas are published on this condition. HPP at initiation of PD is associated with a decrease in both technical and patient survival and might be responsible of ultrafiltration failure. The underlying mechanisms of HPP at initiation of PD also remains unknown.
Read more
To our knowledge, the correlation between hydratation status and peritoneal permeability at initiation of peritoneal dialysis remains unknown. Moreover, there is no datas concerning the cinetic evolution of peritoneal permeability; demographic or biologic factors associated with HPP in days and months following PD start.
The aim of the present study is to correlate hydratation status (attested by bioimpedance) and peritoneal permeability at early start of peritoneal dialysis. Thus, we investigated early cinetic of peritoneal permeability at different time point during the first year of peritoneal dialysis and we analyzed the demographical and biological factors associated with HPP and overhydratation during this period.
This study is a prospective, multicentric cohort study. Fourty patients recruited in a two years' period in five centers of nephrology will be included. Hydratation status will be determined with Fluid Overload measurement by bioimpedance technic thanks to BCM system (Fresenius Medical Care®). Peritoneal permeability will be determined by modified Peritoneal Equilibration Test with complete drainage at sixty minutes. Datas will prospectively be collected, including: weight, blood pressure, diuretic posology, diuresis, PD modality, dialysate prescribed.
- Being tested
- modified Peritoneal Equilibration test
- Keywords
- Fluid overload, Hydratation statud, Peritoneal hypepermeability, Peritoneal dialysis, Impedancemetry
- Medical subject headings
- Edema, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Peritoneal Equilibration testBiological
Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky
- " High ": D/P creatinine>0,8; D/D0 glucose<0,25
- " High average ": 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38
- " Low average ": 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48
- " Low " : D/P creatinine<0,5 ; D/D0 glucose>0,49.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Biological: modified Peritoneal Equilibration test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydratation status
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)
- FO < 10th percentile = extracellular dehydration
- 10th percentile < FO < 90th percentile = extracellular normohydration
- FO > 90th percentile = extracellular hyperhydration
Measured: Day 7
Secondary outcomes (5)
Peritoneal permeability
Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky
- " High ": D/P creatinine>0,8; D/D0 glucose<0,25
- " High average ": 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38
- " Low average ": 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48
- " Low " : D/P creatinine<0,5 ; D/D0 glucose>0,49.
Measured: Day 7
Hydratation status
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)
- FO < 10th percentile = extracellular dehydration
- 10th percentile < FO < 90th percentile = extracellular normohydration
- FO > 90th percentile = extracellular hyperhydration
Measured: Day 45
Peritoneal permeability
Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky
- " High ": D/P creatinine>0,8; D/D0 glucose<0,25
- " High average ": 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38
- " Low average ": 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48
- " Low " : D/P creatinine<0,5 ; D/D0 glucose>0,49.
Measured: Day 45
Hydratation status
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)
- FO < 10th percentile = extracellular dehydration
- 10th percentile < FO < 90th percentile = extracellular normohydration
- FO > 90th percentile = extracellular hyperhydration
Measured: Day 365
Peritoneal permeability
Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky
- " High ": D/P creatinine>0,8; D/D0 glucose<0,25
- " High average ": 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38
- " Low average ": 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48
- " Low " : D/P creatinine<0,5 ; D/D0 glucose>0,49.
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322410
- Sponsor's protocol ID
- PA17003
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
- ClinicalTrials.gov ID
- NCT03322410
- Acronym / sponsor ID
- PA17003
- Keywords
- Fluid overload, Hydratation statud, Peritoneal hypepermeability, Peritoneal dialysis, Impedancemetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 26 Oct 2017 (actual)
- 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.
Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing determination of hydratation status in patients with chronic kidney disease treated with peritoneal dialysis (PD). Overhydratation attested by bioimpedance is strongly associated with cardio-vascular morbidity and mortality in patients with PD. Overhydratation might concern more than half of patients at PD initiation, though the underlying mechanism remains unknown.
High peritoneal permeability (HPP) might concern about a third of patients starting a PD, although only a few datas are published on this condition. HPP at initiation of PD is associated with a decrease in both technical and patient survival and might be responsible of ultrafiltration failure. The underlying mechanisms of HPP at initiation of PD also remains unknown.
To our knowledge, the correlation between hydratation status and peritoneal permeability at initiation of peritoneal dialysis remains unknown. Moreover, there is no datas concerning the cinetic evolution of peritoneal permeability; demographic or biologic factors associated with HPP in days and months following PD start.
The aim of the present study is to correlate hydratation status (attested by bioimpedance) and peritoneal permeability at early start of peritoneal dialysis. Thus, we investigated early cinetic of peritoneal permeability at different time point during the first year of peritoneal dialysis and we analyzed the demographical and biological factors associated with HPP and overhydratation during this period.
This study is a prospective, multicentric cohort study. Fourty patients recruited in a two years' period in five centers of nephrology will be included. Hydratation status will be determined with Fluid Overload measurement by bioimpedance technic thanks to BCM system (Fresenius Medical Care®). Peritoneal permeability will be determined by modified Peritoneal Equilibration Test with complete drainage at sixty minutes. Datas will prospectively be collected, including: weight, blood pressure, diuretic posology, diuresis, PD modality, dialysate prescribed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Biological: modified Peritoneal Equilibration test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- End stage chronic kidney disease
- Ambulatory
- Starting a peritoneal dialysis in one of the participant centers
- Accepting the study protocol
- Age > 18yo
Key exclusion criteria (2 listed)
- Age <18yo
- Protected by the law
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 |
|---|---|---|
| modified Peritoneal Equilibration testPeritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky * " High ": D/P creatinine>0,8; D/D0 glucose<0,25 * " High average ": 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38 * " Low average ": 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48 * " Low " : D/P creatinine<0,5 ; D/D0 glucose>0,49. | Biological | Patients |
Primary outcome
Hydratation status
Time frame: Day 7
Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®) * FO < 10th percentile = extracellular dehydration * 10th percentile < FO < 90th percentile = extracellular normohydration * FO > 90th percentile = extracellular hyperhydration
5 secondary outcomes
Peritoneal permeability
Time frame: Day 7
Hydratation status
Time frame: Day 45
Peritoneal permeability
Time frame: Day 45
Hydratation status
Time frame: Day 365
Peritoneal permeability
Time frame: Day 365
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
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Chronic Heart Failure, CKD Stage 3
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Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
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Dry Weight Reduction Intervention Via Extra Ultrafiltration
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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.
Vincent DUPONT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified Peritoneal Equilibration test in people with Fluid Overload and Peritoneal Hyperpermeability, run by CHU de Reims 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatouma TOURE (0326787638 ext. +33, ftoure@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydratation status (time frame: Day 7). 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 26 Oct 2017.