Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

NCT03080441 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: NIM01
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intradialytic Hypotension

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Phase 1 Group 1

EXPERIMENTAL

pressure stockings worn during dialysis treatment

Device: pressure stockings

Phase 1 Group 2

EXPERIMENTAL

Midodrine before dialysis treatment

Drug: Midodrine

Phase 1 Group 3

EXPERIMENTAL

pressure stocking and Midodrine

Other: pressure stockings and midodrine

Interventions

pressure stockings DEVICE

pressure stockings worn during dialysis throughout treatment period

Phase 1 Group 1

Midodrine DRUG

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

Phase 1 Group 2

pressure stockings and midodrine OTHER

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

Phase 1 Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient refusal
• Currently on Midodrine at the start of the Phase 1, Observation period
• Any known contraindications to Midodrine

Sponsors & Collaborators

• Nimedical: lead

MeSH Terms

Interventions

Stockings, Compression; Midodrine

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: March 15, 2017
• Study Start: November 11, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share