Peritoneal DialysisNCT03864120
Understand the Difference Between Clinical Measured UF and Real UF.
An observational study of Peritoneal Dialysis, run by RenJi Hospital at 1 site in China.
Trial summary
The importance of ultrafiltration (UF) and fluid status in peritoneal dialysis has been increasingly aware of over the last two decades. There is growing body of observational evidence showing that low UF is related to unfavorable outcome especially in anuric patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peritoneal Dialysis
- How many people
- 261 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2019to 30 Dec 2020
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (>18years), both gender, end stage renal disease on PD treatment
Who may be able to join
- Age >18 years
- on PD treatment for at least one month
- signed the consent
Who cannot join
- Peritonitis or recovery from peritonitis for less than one month.
- On any intra peritoneal treatment apart from peritoneal dialysis.
- Evidence of decompensated liver cirrhosis or heart failure.
- Evidence of extra peritoneal leakage, eg. leakage to thoracic cavity, post peritoneal, hernia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understand the Difference Between Clinical Measured Ultrafiltration and Real Ultrafiltration.
The importance of ultrafiltration (UF) and fluid status in peritoneal dialysis has been increasingly aware of over the last two decades. There is growing body of observational evidence showing that low UF is related to unfavorable outcome especially in anuric patients. The other side of the problem of UF is excessive fluid removal could volume deplete patients and result in loss of residual renal function and overexposing the membrane to glucose unnecessarily. UF is a double-edged sword. The correct measure of UF is the bottom line of talking about target.
Measuring UF is supposed to be simple and straight forward. The most common way of measuring UF in clinical practice was to weight the effluent bag and minus the manufacture announced fill volume.
Read more
Until about 10 years ago, the society first aware that the measurement error in such way is not acceptable. Overfil (the actual volume of dialysate fill in the bag is more than announced) problem was raised from then.
However, there are several other problems around this issue. Firstly, when the product has just been produced overfill is different between manufactory.
Secondly, the overfill volume does change over transportation and storage. But it is not clear how big the change is.
Thirdly, most of the clinics weight the dialysate effluent rather than measure the volume in CAPD, although the specific gravity of dialysate is clearly not going to be 1g/ml.
Taking the fact measuring weight is much easier than measuring volume in CAPD, the question behind is to understand how big the difference is and consequently whether it is acceptable.
All the patients enrolled in the study would be asked to collect all dialysate effluent of the day of their routine peritoneal dialysis adequacy study and bring to the hospital. The exact weight of the bag for PET test (2.5% glucose concentration and dwell time of 4 hour) before and after the dwell and volume measured of the effluent. The dialysate electrolyte, glucose, protein and creatinine level would also be measured.
- Conditions
- Peritoneal Dialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
specific gravity of effluent dialysate is different from water (1g/ml)
To describe the specific gravity of effluent dialysate, the exact weight and volume of effluent dialysate bags in the standard peritoneal equivalent test (PET, 2.5% glucose concentration, 2L, dwell time 4 hours) dwell would be measured in different patients.
Measured: For each patient, the outcome would be cross sectional measured at the time the patient does his 6 monthly routine PET test. The data collection time period of the study is 6 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start15 Jun 2019
- Primary completion30 Jun 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zanzhe Yu, RenJi Hospital
- Investigators
- Zanzhe Yu, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864120
- Sponsor's protocol ID
- 仁济2018（078）
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2019
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu Z, Wang Z, Wang Q, Zhang M, Jin H, Ding L, Yan H, Huang J, Jin Y, Davies S, Fang W, Ni Z. Understand the difference between clinical measured ultrafiltrationand real ultrafiltration in peritoneal dialysis. BMC Nephrol. 2021 Nov 15;22(1):382. doi: 10.1186/s12882-021-02589-3.
PubMed 34781890
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understand the Difference Between Clinical Measured Ultrafiltration and Real Ultrafiltration.
- ClinicalTrials.gov ID
- NCT03864120
- Acronym / sponsor ID
- 仁济2018（078）
- Conditions
- Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 6 Mar 2019 (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.
The importance of ultrafiltration (UF) and fluid status in peritoneal dialysis has been increasingly aware of over the last two decades. There is growing body of observational evidence showing that low UF is related to unfavorable outcome especially in anuric patients. The other side of the problem of UF is excessive fluid removal could volume deplete patients and result in loss of residual renal function and overexposing the membrane to glucose unnecessarily. UF is a double-edged sword. The correct measure of UF is the bottom line of talking about target.
Measuring UF is supposed to be simple and straight forward. The most common way of measuring UF in clinical practice was to weight the effluent bag and minus the manufacture announced fill volume.
Until about 10 years ago, the society first aware that the measurement error in such way is not acceptable. Overfil (the actual volume of dialysate fill in the bag is more than announced) problem was raised from then.
However, there are several other problems around this issue. Firstly, when the product has just been produced overfill is different between manufactory.
Secondly, the overfill volume does change over transportation and storage. But it is not clear how big the change is.
Thirdly, most of the clinics weight the dialysate effluent rather than measure the volume in CAPD, although the specific gravity of dialysate is clearly not going to be 1g/ml.
Taking the fact measuring weight is much easier than measuring volume in CAPD, the question behind is to understand how big the difference is and consequently whether it is acceptable.
All the patients enrolled in the study would be asked to collect all dialysate effluent of the day of their routine peritoneal dialysis adequacy study and bring to the hospital. The exact weight of the bag for PET test (2.5% glucose concentration and dwell time of 4 hour) before and after the dwell and volume measured of the effluent. The dialysate electrolyte, glucose, protein and creatinine level would also be measured.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (>18years), both gender, end stage renal disease on PD treatment
Key inclusion criteria (3 listed)
- Age >18 years
- on PD treatment for at least one month
- signed the consent
Key exclusion criteria (4 listed)
- Peritonitis or recovery from peritonitis for less than one month.
- On any intra peritoneal treatment apart from peritoneal dialysis.
- Evidence of decompensated liver cirrhosis or heart failure.
- Evidence of extra peritoneal leakage, eg. leakage to thoracic cavity, post peritoneal, hernia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
specific gravity of effluent dialysate is different from water (1g/ml)
Time frame: For each patient, the outcome would be cross sectional measured at the time the patient does his 6 monthly routine PET test. The data collection time period of the study is 6 month.
To describe the specific gravity of effluent dialysate, the exact weight and volume of effluent dialysate bags in the standard peritoneal equivalent test (PET, 2.5% glucose concentration, 2L, dwell time 4 hours) dwell would be measured in different patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Derived from this study: PubMed 34781890Yu Z, Wang Z, Wang Q, Zhang M, Jin H, Ding L, Yan H, Huang J, Jin Y, Davies S, Fang W, Ni Z. Understand the difference between clinical measured ultrafiltrationand real ultrafiltration in peritoneal dialysis. BMC Nephrol. 2021 Nov 15;22(1):382. doi: 10.1186/s12882-021-02589-3.
- Individual participant dataSharing planned: No
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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.
Zanzhe Yu, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis, run by RenJi Hospital at 1 site in China.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Mar 2021. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
specific gravity of effluent dialysate is different from water (1g/ml) (time frame: For each patient, the outcome would be cross sectional measured at the time the patient does his 6 monthly routine PET test. The data collection time period of the study is 6 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864120, which also lists 1 linked publication.
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 12 Mar 2021.