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Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Primary Purpose

Intradialytic Hypotension

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
pressure stockings
Midodrine
pressure stockings and midodrine
Sponsored by
Nimedical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intradialytic Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Phase 1 Group 1

    Phase 1 Group 2

    Phase 1 Group 3

    Arm Description

    pressure stockings worn during dialysis treatment

    Midodrine before dialysis treatment

    pressure stocking and Midodrine

    Outcomes

    Primary Outcome Measures

    Hypotension
    Post dialysis BP measured in mm/Hg
    Weight
    Post dialysis weight measure in kg
    Cardiac Index
    Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2017
    Last Updated
    March 9, 2017
    Sponsor
    Nimedical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03080441
    Brief Title
    Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
    Official Title
    Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 11, 2016 (Actual)
    Primary Completion Date
    April 1, 2017 (Anticipated)
    Study Completion Date
    May 1, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nimedical

    4. Oversight

    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

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intradialytic Hypotension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase 1 Group 1
    Arm Type
    Experimental
    Arm Description
    pressure stockings worn during dialysis treatment
    Arm Title
    Phase 1 Group 2
    Arm Type
    Experimental
    Arm Description
    Midodrine before dialysis treatment
    Arm Title
    Phase 1 Group 3
    Arm Type
    Experimental
    Arm Description
    pressure stocking and Midodrine
    Intervention Type
    Device
    Intervention Name(s)
    pressure stockings
    Intervention Description
    pressure stockings worn during dialysis throughout treatment period
    Intervention Type
    Drug
    Intervention Name(s)
    Midodrine
    Intervention Description
    administered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure.
    Intervention Type
    Other
    Intervention Name(s)
    pressure stockings and midodrine
    Intervention Description
    combination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period
    Primary Outcome Measure Information:
    Title
    Hypotension
    Description
    Post dialysis BP measured in mm/Hg
    Time Frame
    6 weeks
    Title
    Weight
    Description
    Post dialysis weight measure in kg
    Time Frame
    6 weeks
    Title
    Cardiac Index
    Description
    Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no current plan to share IPD with other researchers

    Learn more about this trial

    Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

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