Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Sponsor

Nimedical (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03080441

Collaborator

(none)

Enrollment

Arms

5.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intradialytic Hypotension	Device: pressure stockings Drug: Midodrine Other: pressure stockings and midodrine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Actual Study Start Date :

Nov 11, 2016

Anticipated Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

May 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nimedical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nimedical

ClinicalTrials.gov Identifier:

NCT03080441

Other Study ID Numbers:

NIM01

First Posted:

Mar 15, 2017

Last Update Posted:

Mar 15, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

Additional relevant MeSH terms:

Hypotension

Midodrine

Study Results

No Results Posted as of Mar 15, 2017