Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Phase 4

• Conditions: Intradialytic Hypotension
• Interventions: Device: pressure stockings; Drug: Midodrine; Other: pressure stockings and midodrine

• Registration Number: NCT03080441
• Lead Sponsor: Nimedical

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.

Study Timeline

• Study Start: 2016-11-11
• Study First Submitted: 2017-02-08
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Study First Posted: 2017-03-15
• Last Update Posted: 2017-03-15
• Primary Completion: 2017-04-01
• Study Completion: 2017-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1 Group 1	pressure stockings	pressure stockings worn during dialysis treatment
Phase 1 Group 2	Midodrine	Midodrine before dialysis treatment
Phase 1 Group 3	pressure stockings and midodrine	pressure stocking and Midodrine

Primary Outcome Measures

Name	Time	Method
Hypotension	6 weeks	Post dialysis BP measured in mm/Hg
Weight	6 weeks	Post dialysis weight measure in kg
Cardiac Index	1 week	Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2