Disorders Associated With Peritoneal DialysisPhase 2FLUIDNCT01045980
Assessment of Bioimpedance and Vitamin D and LV Mass in PD Patients (FLUID Study)
A Phase 2 study testing Bioimpedance and Vitamin D in people with Disorders Associated With Peritoneal Dialysis, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
Trial summary
The main purpose of this study is to compare the effects of using bio-impedance analysis to guide management of fluid status versus routine clinical care on heart structure. In addition, Vitamin D is being assessed to determine its effect on heart structure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders Associated With Peritoneal Dialysis
- What is being tested?
- Bioimpedance and Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Aug 2010to 30 Nov 2016
- Phase
- Phase 2
- 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
- Age ≥18 years
- on peritoneal dialysis
Who cannot join
- Contraindication to MRI including presence of a pacemaker, defibrillator, ferromagnetic cerebral aneurysm clips, cochlear implants or eye prosthesis, neurostimulators, shrapnel in vital locations, surgery within 6 weeks, severe claustrophobia and severe obesity
- Previous amputation
- Life or technique expectancy < 1 year
- Pregnancy
- Peritonitis in previous 3 months
- Currently using more than one extraneal bag per 24-hours
Show all 11Show fewer
- Known icodextrin allergy
- Currently using non-Baxter PD solutions
- Inability to provide consent
- Allergy to cholecalciferol
- Serum Calcium > 2.55 mmol/L
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N4A6
Population Health Research Institute - McMaster University
Hamilton, Ontario
About this study
Official title: The Effect of Bio-impedance Analysis and Vitamin D Versus Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: a Randomized Controlled Trial
The main purpose of this study is to compare the effects of using bio-impedance analysis to guide management of fluid status versus routine clinical care on heart structure. In addition, Vitamin D is being assessed to determine its effect on heart structure.
Read the detailed description
Patients on peritoneal dialysis are frequently hypervolemic which is associated with deleterious changes in left ventricular (LV) architecture including increased LV mass. In dialysis patients, increased LV mass is associated with death. Recent randomized trials have demonstrated that increasing small solute clearance is not associated with improved outcomes - hence an increased interest in the management of volume control in ESRD patients. Bioimpedance analysis is inexpensive, safe and easy to use and appears to be more useful than other techniques to assess volume status in dialysis patients. In addition, dialysis patients are vitamin D deficient and this is also associated with an increased LV mass and its inherent complications.
This study will evaluate the use of bioimpedance analysis versus usual care to assess and manage volume status and the use of vitamin D versus placebo in peritoneal dialysis patients and its effect on LV mass as measured by cardiac MRI.
- Being tested
- Bioimpedance and Vitamin D, Usual care and placebo, Usual care and Vitamin D, Bioimpedance and Placebo
- Keywords
- Peritoneal dialysis, Impedance, bioelectric, Hypertrophy, left ventricular, Fluid status, Volume overload, Congestive heart failure, Cardiovascular outcomes, Randomized controlled trial
- Medical subject headings
- Hypertrophy, Left Ventricular, Edema, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance and Vitamin DDrug
Intervention subjects will undergo BIA assessment monthly for 1 year, and then every 3 months until the end of the planned 3-year study. Protocolized interventions to achieve euvolemia will occur based on the BIA result and they include sodium restriction, addition of diuretics, use of icodextrin, and additional rational changes to the PD prescription.
Usual care and placeboDrug
Usual care (not bioimpedance guided volume management) and Placebo
Usual care and Vitamin DDrug
Usual care (not bioimpedance guided volume management) and Vitamin D
Bioimpedance and PlaceboDevice
Bioimpedance guided volume management and Placebo
| Study group | Role | What they receive |
|---|---|---|
| Bioimpedance and Vitamin D | Experimental | Bioimpedance and Vitamin D Receives: Drug: Bioimpedance and Vitamin D |
| Usual care and Vitamin D | Experimental | Usual Care and Vitamin D3 Receives: Drug: Usual care and Vitamin D |
| Bioimpedance and Placebo | Experimental | Bioimpedance and Placebo Receives: Device: Bioimpedance and Placebo |
| Usual Care and Placebo | Placebo comparator | Usual Care and Placebo Receives: Drug: Usual care and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass measured by cardiac MRI
Measured: 1 year
Secondary outcomes (9)
Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure
Measured: 3 years
Volume measures: bio-impedance (RXc graph, vector length, impedance ratio, phase angle, ECW:TBW ratio), weight, N-BNP, mean and pulse arterial pressure, number of anti-hypertensive agents
Measured: 3 years
Health-related quality of life (HRQOL)
Measured: 1 year
Physical function as measured by 6 minute walk test
Measured: 1 year
Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a
Measured: 1 year
Peritoneal membrane transport properties,measured by PET
Measured: 3 years
Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume
Measured: 3 years
left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI
Measured: 1 year
Fraility Score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study start1 Aug 2010
- Primary completion15 May 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorders Associated With Peritoneal DialysisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Azim S Gangji, MD MSc FRCPC, Principal investigator, St. Joseph's Healthcare HamiltonK S Brimble, MD MSc FRCPC, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045980
- Sponsor's protocol ID
- SJH-Renal-RCT-003
- Acronym
- FLUID
- Status last verified
- May 2025
- First submitted
- 8 Jan 2010
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brimble KS, Ganame J, Margetts P, Jain A, Perl J, Walsh M, Bosch J, Yusuf S, Beshay S, Su W, Zimmerman D, Lee SF, Gangji AS. Impact of Bioelectrical Impedance-Guided Fluid Management and Vitamin D Supplementation on Left Ventricular Mass in Patients Receiving Peritoneal Dialysis: A Randomized Controlled Trial. Am J Kidney Dis. 2022 Jun;79(6):820-831. doi: 10.1053/j.ajkd.2021.08.022. Epub 2021 Oct 14.
PubMed 34656640Su WS, Gangji AS, Margetts PM, Bosch J, Yusuf S, Clase CM, Ganame J, Noseworthy M, Lonn E, Jain AK, McCormick B, Brimble KS. The fluid study protocol: a randomized controlled study on the effects of bioimpedance analysis and vitamin D on left ventricular mass in peritoneal dialysis patients. Perit Dial Int. 2011 Sep-Oct;31(5):529-36. doi: 10.3747/pdi.2010.00232. Epub 2011 May 31.
PubMed 21632446
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bio-impedance Analysis and Vitamin D Versus Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01045980
- Acronym / sponsor ID
- FLUID / SJH-Renal-RCT-003
- Keywords
- Peritoneal dialysis, Impedance, bioelectric, Hypertrophy, left ventricular, Fluid status, Volume overload, Congestive heart failure, Cardiovascular outcomes, Randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 11 Jan 2010 (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 main purpose of this study is to compare the effects of using bio-impedance analysis to guide management of fluid status versus routine clinical care on heart structure. In addition, Vitamin D is being assessed to determine its effect on heart structure.
Detailed description
Patients on peritoneal dialysis are frequently hypervolemic which is associated with deleterious changes in left ventricular (LV) architecture including increased LV mass. In dialysis patients, increased LV mass is associated with death. Recent randomized trials have demonstrated that increasing small solute clearance is not associated with improved outcomes - hence an increased interest in the management of volume control in ESRD patients. Bioimpedance analysis is inexpensive, safe and easy to use and appears to be more useful than other techniques to assess volume status in dialysis patients. In addition, dialysis patients are vitamin D deficient and this is also associated with an increased LV mass and its inherent complications.
This study will evaluate the use of bioimpedance analysis versus usual care to assess and manage volume status and the use of vitamin D versus placebo in peritoneal dialysis patients and its effect on LV mass as measured by cardiac MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bioimpedance and Vitamin D | Experimental | Drug: Bioimpedance and Vitamin DBioimpedance and Vitamin D |
| Usual care and Vitamin D | Experimental | Drug: Usual care and Vitamin DUsual Care and Vitamin D3 |
| Bioimpedance and Placebo | Experimental | Device: Bioimpedance and PlaceboBioimpedance and Placebo |
| Usual Care and Placebo | Placebo comparator | Drug: Usual care and placeboUsual Care and Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- on peritoneal dialysis
Key exclusion criteria (11 listed)
- Contraindication to MRI including presence of a pacemaker, defibrillator, ferromagnetic cerebral aneurysm clips, cochlear implants or eye prosthesis, neurostimulators, shrapnel in vital locations, surgery within 6 weeks, severe claustrophobia and severe obesity
- Previous amputation
- Life or technique expectancy < 1 year
- Pregnancy
- Peritonitis in previous 3 months
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 and Vitamin DIntervention subjects will undergo BIA assessment monthly for 1 year, and then every 3 months until the end of the planned 3-year study. Protocolized interventions to achieve euvolemia will occur based on the BIA result and they include sodium restriction, addition of diuretics, use of icodextrin, and additional rational changes to the PD prescription. | Drug | Bioimpedance and Vitamin D |
| Usual care and placeboUsual care (not bioimpedance guided volume management) and Placebo | Drug | Usual Care and Placebo |
| Usual care and Vitamin DUsual care (not bioimpedance guided volume management) and Vitamin D | Drug | Usual care and Vitamin D |
| Bioimpedance and PlaceboBioimpedance guided volume management and Placebo | Device | Bioimpedance and Placebo |
Primary outcome
Left ventricular mass measured by cardiac MRI
Time frame: 1 year
9 secondary outcomes
Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure
Time frame: 3 years
Volume measures: bio-impedance (RXc graph, vector length, impedance ratio, phase angle, ECW:TBW ratio), weight, N-BNP, mean and pulse arterial pressure, number of anti-hypertensive agents
Time frame: 3 years
Health-related quality of life (HRQOL)
Time frame: 1 year
Physical function as measured by 6 minute walk test
Time frame: 1 year
Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a
Time frame: 1 year
Peritoneal membrane transport properties,measured by PET
Time frame: 3 years
Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume
Time frame: 3 years
left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI
Time frame: 1 year
Fraility Score
Time frame: 1 year
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 18 May 2025.
- Derived from this study: PubMed 34656640Brimble KS, Ganame J, Margetts P, Jain A, Perl J, Walsh M, Bosch J, Yusuf S, Beshay S, Su W, Zimmerman D, Lee SF, Gangji AS. Impact of Bioelectrical Impedance-Guided Fluid Management and Vitamin D Supplementation on Left Ventricular Mass in Patients Receiving Peritoneal Dialysis: A Randomized Controlled Trial. Am J Kidney Dis. 2022 Jun;79(6):820-831. doi: 10.1053/j.ajkd.2021.08.022. Epub 2021 Oct 14.
- Derived from this study: PubMed 21632446Su WS, Gangji AS, Margetts PM, Bosch J, Yusuf S, Clase CM, Ganame J, Noseworthy M, Lonn E, Jain AK, McCormick B, Brimble KS. The fluid study protocol: a randomized controlled study on the effects of bioimpedance analysis and vitamin D on left ventricular mass in peritoneal dialysis patients. Perit Dial Int. 2011 Sep-Oct;31(5):529-36. doi: 10.3747/pdi.2010.00232. Epub 2011 May 31.
- Hamilton Centre for Kidney ResearchLink provided by the sponsor.
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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.
Azim S Gangji, MD MSc FRCPC principal investigator
St. Joseph's Healthcare Hamilton
K S Brimble, MD MSc FRCPC principal investigator
St. Joseph's Healthcare Hamilton
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bioimpedance and Vitamin D in people with Disorders Associated With Peritoneal Dialysis, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
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 2 inclusion and 11 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 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Left ventricular mass measured by cardiac MRI (time frame: 1 year). 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 NCT01045980, which also lists 2 linked publications.
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 18 May 2025.