Official Title
Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
Phase
Phase 4Lead Sponsor
NimedicalStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Intradialytic HypotensionIntervention/Treatment
midodrine ...Study Participants
35This 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.
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.
pressure stockings worn during dialysis throughout treatment period
administered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure.
combination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period
pressure stockings worn during dialysis treatment
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
