End Stage Renal DiseaseNCT02000128
Fluid Management Guided by Bioimpedance Analysis in Peritoneal Dialysis(PD) Patients.
A study testing bioimpedance monitoring and clinical monitoring in people with End Stage Renal Disease, run by Sun Yat-sen University at 1 site in China.
Trial summary
1. Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients. 2. Design: prospective,randomized,controlled,single center study 3. 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?
- bioimpedance monitoring and clinical monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Apr 2015
- 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 who are undergoing peritoneal dialysis and clinically stable for at least 3 months;
- 18 Years and older;
- ratio extracellular water (ECW)/total body water(TBW)≧0.4;
- signed the informed consent
Who cannot join
- patients who have mental graft;
- amputation;
- patients who is unable to accomplish the BIA measurement in standing position for 3 minutes;
- patients whose heart function are class IV estimated by New York Heart Association (NYHA) standard;
- Patients who have acute complications within 30 days prior to study enrollment;
- patients whose life expectancy is within 6 months;
- patients who are pregnant;
- patients who are unable to give consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
About this study
Official title: A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.
- Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
- Design: prospective,randomized,controlled,single center study
- Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is associated with increasing hazard of death and cardiovascular events. Bioimpedance analysis is a safe, and easy way, which appears to be more useful and sensitive than other techniques for assessing volume status in dialysis patients. Therefore we hypothesize that more concise and strict fluid management guided by BIA may help to improve patients' survival, decrease cardiovascular events and hospitalization rate.
- Objects: incident and prevalent patients with overhydration status.
- anticipated cases:240
- arms: all the patients are randomized into two arms.(BIA group/clinical group)
- observational time:12 months
- Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.
- Conditions
- End Stage Renal Disease
- Being tested
- bioimpedance monitoring, clinical monitoring
- Keywords
- Peritoneal Dialysis, fluid overload, bioimpedance analysis, Randomized Controlled Trial
- Medical subject headings
- Kidney Failure, Chronic, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioimpedance monitoringDevice
Also called Multi-frequency bioelectrical impedance analysis, Body Composition Analyzer
To assess the body composition using Multi-frequency bioelectrical impedance analysis
clinical monitoringOther
Also called routine method of assessing water status
clinical symptom and examination,such as edema, body weight, blood pressure, cardial function
| Study group | Role | What they receive |
|---|---|---|
| bioimpedance monitoring group | Experimental | patients whose fluid status will be monitored and guided by bioimpedance analysis Receives: Device: bioimpedance monitoring |
| clinical monitoring group | Other | patients whose fluid status will be monitored and guided by clinical experience Receives: Other: clinical monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
all cause mortality;cardiovascular related mortality
Measured: 12 months
Secondary outcomes (4)
technique failure
permanent hemodialysis transfer
Measured: 12 months
cardiovascular events
heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting,
Measured: 12 months
clinical adverse events
hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy
Measured: 12 months
residual renal function
change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2015
- Study completionApr 2015
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 Sun Yat-sen UniversityThe 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
- Investigators
- Xuqing Yu, MD,PHD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000128
- Sponsor's protocol ID
- SYSU-PD-BIA
- Status last verified
- Apr 2016
- First submitted
- 26 Nov 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.
- ClinicalTrials.gov ID
- NCT02000128
- Acronym / sponsor ID
- SYSU-PD-BIA
- Conditions
- End Stage Renal Disease
- Keywords
- Peritoneal Dialysis, fluid overload, bioimpedance analysis, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Dec 2013 (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.
- Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
- Design: prospective,randomized,controlled,single center study
- Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is associated with increasing hazard of death and cardiovascular events. Bioimpedance analysis is a safe, and easy way, which appears to be more useful and sensitive than other techniques for assessing volume status in dialysis patients. Therefore we hypothesize that more concise and strict fluid management guided by BIA may help to improve patients' survival, decrease cardiovascular events and hospitalization rate.
- Objects: incident and prevalent patients with overhydration status.
- anticipated cases:240
- arms: all the patients are randomized into two arms.(BIA group/clinical group)
- observational time:12 months
- Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bioimpedance monitoring group | Experimental | Device: bioimpedance monitoringpatients whose fluid status will be monitored and guided by bioimpedance analysis |
| clinical monitoring group | Other | Other: clinical monitoringpatients whose fluid status will be monitored and guided by clinical experience |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who are undergoing peritoneal dialysis and clinically stable for at least 3 months;
- 18 Years and older;
- ratio extracellular water (ECW)/total body water(TBW)≧0.4;
- signed the informed consent
Key exclusion criteria (8 listed)
- patients who have mental graft;
- amputation;
- patients who is unable to accomplish the BIA measurement in standing position for 3 minutes;
- patients whose heart function are class IV estimated by New York Heart Association (NYHA) standard;
- Patients who have acute complications within 30 days prior to study enrollment;
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 |
|---|---|---|
| bioimpedance monitoringAlso: Multi-frequency bioelectrical impedance analysis, Body Composition AnalyzerTo assess the body composition using Multi-frequency bioelectrical impedance analysis | Device | bioimpedance monitoring group |
| clinical monitoringAlso: routine method of assessing water statusclinical symptom and examination,such as edema, body weight, blood pressure, cardial function | Other | clinical monitoring group |
Primary outcome
death
Time frame: 12 months
all cause mortality;cardiovascular related mortality
4 secondary outcomes
technique failure
Time frame: 12 months
cardiovascular events
Time frame: 12 months
clinical adverse events
Time frame: 12 months
residual renal function
Time frame: 12 months
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 20 Apr 2016.
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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.
Xuqing Yu, MD,PHD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioimpedance monitoring and clinical monitoring in people with End Stage Renal Disease, run by Sun Yat-sen University 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 4 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 20 Apr 2016. 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?
death (time frame: 12 months). 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 20 Apr 2016.