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| Name | Class |
|---|---|
| Population Health Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioimpedance and Vitamin D | Experimental | Bioimpedance and Vitamin D |
|
| Usual care and Vitamin D | Experimental | Usual Care and Vitamin D3 |
|
| Bioimpedance and Placebo | Experimental | Bioimpedance and Placebo |
|
| Usual Care and Placebo | Placebo Comparator | Usual Care and Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioimpedance and Vitamin D | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular mass measured by cardiac MRI | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Combined outcome of death, non-fatal CV event (stroke, MI, amputation, CHF), and transfer to HD for inadequacy or ultrafiltration failure | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Azim S Gangji, MD MSc FRCPC | St. Joseph's Healthcare Hamilton | Principal Investigator |
| K S Brimble, MD MSc FRCPC | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N4A6 | Canada | ||
| Population Health Research Institute - McMaster University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34656640 | Derived | 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. | |
| 21632446 |
| Label | URL |
|---|---|
| Hamilton Centre for Kidney Research | View source |
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| ID | Term |
|---|---|
| D017379 | Hypertrophy, Left Ventricular |
| D004487 | Edema |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
| Usual care and placebo | Drug | Usual care (not bioimpedance guided volume management) and Placebo |
|
| Usual care and Vitamin D | Drug | Usual care (not bioimpedance guided volume management) and Vitamin D |
|
| Bioimpedance and Placebo | Device | Bioimpedance guided volume management and Placebo |
|
| 3 years |
| Health-related quality of life (HRQOL) | 1 year |
| Physical function as measured by 6 minute walk test | 1 year |
| Serum and peritoneal inflammatory and fibrotic markers: albumin, CRP, IL-6, TNF-a | 1 year |
| Peritoneal membrane transport properties,measured by PET | 3 years |
| Renal and peritoneal solute clearance, 24-hour urine output and ultrafiltration volume | 3 years |
| left ventricular end-diastolic and systolic volumes, stroke volume and ejection fraction measure by MRI | 1 year |
| Fraility Score | 1 year |
| Hamilton |
| Ontario |
| Canada |
| Derived |
| Su 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |