Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Intradialytic Hypotension Clinical Trial

Official title:

Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03080441
• Other study ID #: NIM01
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: February 8, 2017
• Last updated: March 9, 2017
• Start date: November 11, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: March 2017
• Source: Nimedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: May 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intradialytic Hypotension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nimedical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension	Post dialysis BP measured in mm/Hg	6 weeks
Primary	Weight	Post dialysis weight measure in kg	6 weeks
Primary	Cardiac Index	Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2	1 week