End Stage Renal DiseaseNCT03004963
Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.
A study testing Body composition monitor and clinical indexes in people with End Stage Renal Disease, run by RenJi Hospital at 1 site in China.
Trial summary
Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Body composition monitor and clinical indexes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older but no older than 80 years.
- who had been on chronic peritoneal dialysis for more than 3 months.
- All of them have signed the informed consent.
Who cannot join
- were expected to stop PD treatment in 6 months;
- were amputees;
- had a cardiac pacemaker or metallic implants;
- had peritonitis one month before recruitment;
- treated together with hemodialysis;
- were during pregnancy or lactation;
- were positive with HIV;
- had serious diseases, including cancer, infection and liver cirrhosis, which were not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients: A Randomized Controlled Trial
Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of overhydration in PD patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.
Read the detailed description
Optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (PD) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. Body Composition Monitor (BCM) has the potential to enable better management of fluid balance. The investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal BCM measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.
- Conditions
- End Stage Renal Disease
- Being tested
- Body composition monitor, clinical indexes
- Keywords
- Peritoneal Dialysis, Volume Status, Body Composition Monitor
- 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.
Body composition monitorDevice
Both body composition monitor (BCM) is used to evaluate the volume status of patients.
clinical indexesDevice
The investigators evaluate the volume status of patients according to clinical indexes.
| Study group | Role | What they receive |
|---|---|---|
| clinical group | Active comparator | evaluate the volume status just according to clinical indexes in this group. Receives: Device: clinical indexes |
| clinical and BCM group | Experimental | Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group. Receives: Device: Body composition monitor; Device: clinical indexes |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume status
change in overhydration(OH) value
Measured: 96 weeks
The incidence of cardiovascular events
different incidence of cardiovascular diseases
Measured: 96 weeks
patient mortality
different rates of all-cause patient mortality and cardiovascular mortality
Measured: 96 weeks
technique failure
different incidence of technique failure during peritoneal dialysis treatment
Measured: 96 weeks
Secondary outcomes (4)
blood pressure
change in blood pressure
Measured: 96 weeks
residual renal function
decline rate of residual renal function
Measured: 96 weeks
peritoneal function
differences of peritoneal solute transport rate
Measured: 96 weeks
heart function
differences of ejection fraction (EF) in echocardiography
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2020
- Study completionNov 2020
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Fang, Dr, Principal investigator, Department of Nephrology, Renji Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004963
- Sponsor's protocol ID
- [2016]101K
- Status last verified
- Nov 2024
- First submitted
- 12 Dec 2016
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03004963
- Acronym / sponsor ID
- [2016]101K
- Conditions
- End Stage Renal Disease
- Keywords
- Peritoneal Dialysis, Volume Status, Body Composition Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 29 Dec 2016 (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.
Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of overhydration in PD patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.
Detailed description
Optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (PD) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. Body Composition Monitor (BCM) has the potential to enable better management of fluid balance. The investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal BCM measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinical group | Active comparator | Device: clinical indexesevaluate the volume status just according to clinical indexes in this group. |
| clinical and BCM group | Experimental | Device: Body composition monitor, Device: clinical indexesBoth body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years or older but no older than 80 years.
- who had been on chronic peritoneal dialysis for more than 3 months.
- All of them have signed the informed consent.
Key exclusion criteria (8 listed)
- were expected to stop PD treatment in 6 months;
- were amputees;
- had a cardiac pacemaker or metallic implants;
- had peritonitis one month before recruitment;
- treated together with hemodialysis;
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 |
|---|---|---|
| Body composition monitorBoth body composition monitor (BCM) is used to evaluate the volume status of patients. | Device | clinical and BCM group |
| clinical indexesThe investigators evaluate the volume status of patients according to clinical indexes. | Device | clinical and BCM group, clinical group |
Primary outcome
volume status
Time frame: 96 weeks
change in overhydration(OH) value
The incidence of cardiovascular events
Time frame: 96 weeks
different incidence of cardiovascular diseases
patient mortality
Time frame: 96 weeks
different rates of all-cause patient mortality and cardiovascular mortality
technique failure
Time frame: 96 weeks
different incidence of technique failure during peritoneal dialysis treatment
4 secondary outcomes
blood pressure
Time frame: 96 weeks
residual renal function
Time frame: 96 weeks
peritoneal function
Time frame: 96 weeks
heart function
Time frame: 96 weeks
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 22 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Wei Fang, Dr principal investigator
Department of Nephrology, Renji Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body composition monitor and clinical indexes in people with End Stage Renal Disease, 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 8 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 22 Nov 2024. 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?
volume status (time frame: 96 weeks). The study lists 4 primary outcomes in all. 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 22 Nov 2024.