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Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03080441
Enrollment
35
Registered
2017-03-15
Start date
2016-11-11
Completion date
2017-05-01
Last updated
2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intradialytic Hypotension

Brief summary

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

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.

Interventions

DEVICEpressure stockings

pressure stockings worn during dialysis throughout treatment period

DRUGMidodrine

administered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure.

OTHERpressure stockings and midodrine

combination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period

Sponsors

Nimedical
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hypotension6 weeksPost dialysis BP measured in mm/Hg
Weight6 weeksPost dialysis weight measure in kg
Cardiac Index1 weekCardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026