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This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. It also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist | |
| IBPS Group | Experimental | This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradialytic Blood Pressure Slope Based Ultrafiltration | Other | Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Ambulatory Systolic Blood Pressure | The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months) | Baseline, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Extracellular Volume/Body Weight Ratio | expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month | Baseline, 4 months |
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Inclusion Criteria:
Exclusion Criteria:
Bioimpedance will not be peformed on patients with
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| Name | Affiliation | Role |
|---|---|---|
| Peter Van Buren, MD, MSCS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davita Dialysis | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist |
| FG001 | IBPS Group | This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist |
| BG001 | IBPS Group | This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 intervention subjects withdrew prior to study intervention starting |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Ambulatory Systolic Blood Pressure | The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months) | Posted | Mean | Standard Deviation | mmHg | Baseline, 4 months |
|
Adverse events were determined over a 4 month period per subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intradialytic Hypotension | Blood and lymphatic system disorders | Patient interaction | Systematic Assessment | At least one episode of systolic blood pressure <90 mmHg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Van Buren | University of Texas Southwestern Medical Center | 214-645-8293 | peter.vanburen@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2017 | Mar 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3 | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3 | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3 | Count of Participants | Participants |
|
| Race (NIH/OMB) | Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3 | Count of Participants | Participants |
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| Region of Enrollment | Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3 | Count of Participants | Participants |
|
| Diabetes | Due to two withdrawals in the intervention group (never began the intervention) the comparison is with 9 vs 3 | Count of Participants | Participants |
|
|
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| Secondary | Change in Extracellular Volume/Body Weight Ratio | expected reduction of at least 0.025 greater reduction for IBPS compared to standard care The change in ECV/body weight from baseline to 4 month | In the Standard of Care arm/ group, it was not possible to obtain these measurements in 3 subjects (amputations, defibrillators, implanted metal) and are missing the data since they were unable to undergo these measurements. | Posted | Mean | Standard Deviation | L/kg | Baseline, 4 months |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 5 |
| 9 |
| EG001 | IBPS Group | This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period. Intradialytic Blood Pressure Slope Based Ultrafiltration: Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments | 0 | 3 | 0 | 3 | 3 | 3 |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |