Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

NCT ID: NCT03080441

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-11
• Study Completion Date: 2017-05-01

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.

Conditions

Intradialytic Hypotension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 Group 1

pressure stockings worn during dialysis treatment

Group Type: EXPERIMENTAL

pressure stockings

Intervention Type: DEVICE

pressure stockings worn during dialysis throughout treatment period

Phase 1 Group 2

Midodrine before dialysis treatment

Group Type: EXPERIMENTAL

Midodrine

Intervention Type: DRUG

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

Phase 1 Group 3

pressure stocking and Midodrine

Group Type: EXPERIMENTAL

pressure stockings and midodrine

Intervention Type: OTHER

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

Interventions

pressure stockings

pressure stockings worn during dialysis throughout treatment period

Intervention Type: DEVICE

Midodrine

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

Intervention Type: DRUG

pressure stockings and midodrine

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nimedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NIM01

Identifier Type: -

Identifier Source: org_study_id