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Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
midodrine
Placebo
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute Kidney Injury, midodrine, intensive care unit

Eligibility Criteria

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

Inclusion Criteria:

  • ICU patients
  • acute kidney injury
  • age above 18 years
  • documented hypotension during dialysis

Exclusion Criteria:

  • packed red blood cells transfusion
  • intravenous inotropes
  • alteration of blood pressure medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    midodrine group

    placebo group

    Arm Description

    Patients will receive midodrine tablets

    Patients receive sugary oral tablets therapy

    Outcomes

    Primary Outcome Measures

    Number of hypotensive episodes
    Number of hypotensive episodes

    Secondary Outcome Measures

    mean systolic blood pressure
    compare mean systolic blood pressure between the two arms
    mean diastolic blood pressure
    compare mean diastolic blood pressure between the two arms
    Mortality in each arm
    Number of dead patients in each arm

    Full Information

    First Posted
    February 7, 2018
    Last Updated
    August 19, 2022
    Sponsor
    Benha University
    Collaborators
    New Jeddah Clinic Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03431194
    Brief Title
    Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury
    Official Title
    Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    February 19, 2017 (Actual)
    Study Completion Date
    April 6, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Benha University
    Collaborators
    New Jeddah Clinic Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the management of intradialytic hypotension among critically ill patients with acute kidney injury.
    Detailed Description
    In This open -label study, patients in ICU with acute kidney injury are randomized to either midodrine tablets or placebo. the number of intradialytic episodes and both systolic and diastolic blood pressure between both groups are compared. Mortality and adverse effects are monitored and compared as well.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury
    Keywords
    Acute Kidney Injury, midodrine, intensive care unit

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    midodrine group
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive midodrine tablets
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients receive sugary oral tablets therapy
    Intervention Type
    Drug
    Intervention Name(s)
    midodrine
    Intervention Description
    oral midodrine tablets 5 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Number of hypotensive episodes
    Description
    Number of hypotensive episodes
    Time Frame
    30 days from start of hemodialysis
    Secondary Outcome Measure Information:
    Title
    mean systolic blood pressure
    Description
    compare mean systolic blood pressure between the two arms
    Time Frame
    30 days from start of hemodialysis
    Title
    mean diastolic blood pressure
    Description
    compare mean diastolic blood pressure between the two arms
    Time Frame
    30 days from start of hemodialysis
    Title
    Mortality in each arm
    Description
    Number of dead patients in each arm
    Time Frame
    30 days from start of hemodialysis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ICU patients acute kidney injury age above 18 years documented hypotension during dialysis Exclusion Criteria: packed red blood cells transfusion intravenous inotropes alteration of blood pressure medications

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury

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