Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

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.

Study Overview

• Status: Unknown
• Conditions: Intradialytic Hypotension
• Intervention / Treatment: Device: pressure stockings; Drug: Midodrine; Other: pressure stockings and midodrine

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nimedical

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Adrenergic alpha-1 Receptor Agonists; Midodrine
• Other Study ID Numbers: NIM01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no current plan to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes