Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

Study Overview
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Brief Summary
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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.

Official Title
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Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial

Conditions
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ESRD, Extracellular Fluid Alteration, Hypertension

Intervention / Treatment
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* Other: Intradialytic Blood Pressure Slope Based Ultrafiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years End Stage Renal Disease on Maintenance Hemodialysis Hypertension defined as systolic blood pressure > 140 mmHg pre-dialysis or >130 mmHg post dialysis Exclusion Criteria: Hemodialysis Vintage < 1 month Pregnancy Nadir Systolic Blood Pressure < 95 mmHg Pre or Post dialysis systolic blood pressure > 180 mmHg Decrease in systolic blood pressure >60 mmHg from pre to post dialysis Ultrafiltration rate >13 mL/kg/hr Peridialytic Midodrine Use Intradialytic Clonidine use Documented Antihypertensive Medication Non-adherence Bioimpedance will not be peformed on patients with amputated arms or legs cardiac defibrillator or pacemaker presence of metal prostheses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist | |
| Experimental: IBPS Group<br>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. | Other: Intradialytic Blood Pressure Slope Based Ultrafiltration<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |