Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Study Overview
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Brief Summary
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This is a research study to test the application of FDA-approved, non-invasive device (NICaS) that measure the performance of your heart during HD treatment.

Detailed Description
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The incidence of intradialytic hypotension (IDH) events, reported to occur in 15% to 50% of hemodialysis (HD) treatments, is still high despite major technical advances in HD technology. By definition, excessive reduction in intravascular volume by ultrafiltration and limited vascular refilling from tissues into the vascular space is the cause of IDH. Chronic HD patients exhibit a high prevalence of peripheral vascular and cardiac abnormalities. Specifically, hemodynamic instability during HD can occur due to insufficient reduction in venous unstressed volume, poor diastolic filling under reduced atrial pressures associated with diastolic dysfunction, altered cardiac contractility, and impaired vascular reactivity. An IDH event can lead to myocardial cerebral and other organ ischemia. Long- and short-term adverse outcomes have been associated with IDH, a common HD complication and significant cause of morbidity. Recent pilot studies suggest that in IDH-prone subjects, measurements of hemodynamic variables during HD can be used to categorize the hemodynamic response into three subgroups: cardiac power index (CPI) reduction with stable total peripheral resistance (TPR), TPR reduction with stable CPI, and reduction in TPR and CPI groups. It is hypothesized that targeted intervention for each subgroup can reduce IDH.

Official Title
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Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Conditions
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Intradialytic Hypotension

Intervention / Treatment
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* Device: pressure stockings
* Drug: Midodrine
* Other: pressure stockings and midodrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Have been on maintenance hemodialysis at the facility for at least six months Have not had un-excused missed treatments for six months Is symptomatic to HD treatments Males and non-pregnant/non-nursing females, as confirmed via urine pregnancy testing of women of child bearing potential Exclusion Criteria: Patient refusal Currently on Midodrine at the start of the Phase 1, Observation period Any known contraindications to Midodrine

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1 Group 1<br>pressure stockings worn during dialysis treatment | Device: pressure stockings<br>* pressure stockings worn during dialysis throughout treatment period<br>|
| Experimental: Phase 1 Group 2<br>Midodrine before dialysis treatment | Drug: Midodrine<br>* administered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure.<br>|
| Experimental: Phase 1 Group 3<br>pressure stocking and Midodrine | Other: pressure stockings and midodrine<br>* combination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Post dialysis BP measured in mm/Hg | 6 weeks | 
| Weight | Post dialysis weight measure in kg | 6 weeks | 
| Cardiac Index | Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2 | 1 week |