NCT03080441

Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Nimedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intradialytic Hypotension

Interventions

Type	Name	Description
DEVICE	pressure stockings	pressure stockings worn during dialysis throughout treatment period
DRUG	Midodrine	administered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure.
OTHER	pressure stockings and midodrine	combination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period

Timeline

• Start date: 2016-11-11
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2017-03-15
• Last updated: 2017-03-15

Regulatory

• FDA-regulated drug study
• FDA-regulated device study