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Midodrine During Recovery From Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02771158
Recruitment Status : Withdrawn (Study never started)
First Posted : May 12, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Northwell Health

Brief Summary:
The purpose of this study is to determine whether midodrine administration decreases duration of intravenous vasopressors and intensive care unit length of stay for patients in septic shock.

Condition or disease Intervention/treatment Phase
Hypotension Shock, Septic Sepsis Drug: Midodrine Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Midodrine During Recovery Phase From Septic Shock
Estimated Study Start Date : August 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: midodrine
randomization to midodrine 20 mg every 8 hours to be increased to a maximum of 40 mg every 8 hours until intravenous vasopressor discontinuation
Drug: Midodrine
midodrine is metabolized to an active metabolite, desglymidodrine, which is an alpha adrenergic antagonist that causes vasoconstriction of both venous and arterial vasculature, thereby increasing blood pressure
Other Name: proamatine

Placebo Comparator: placebo
randomization to placebo control
Drug: placebo
placebo will be administered to double blind the study




Primary Outcome Measures :
  1. duration of intravenous vasopressors [ Time Frame: from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days ]

Secondary Outcome Measures :
  1. intensive care unit length of stay [ Time Frame: from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days ]
  2. re-institution of intravenous vasopressor [ Time Frame: from enrollment until hospital discharge, expected to be up to 30 days ]
  3. hospital length of stay [ Time Frame: from enrollment until hospital discharge, expected to be up to 30 days ]
  4. mortality [ Time Frame: from enrollment until hospital discharge, expected to be up to 30 days ]
  5. midodrine side effects requiring discontinuation [ Time Frame: from enrollment until hospital discharge, expected to be up to 30 days ]
    including supine hypertension and bradycardia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • admitted to intensive care unit
  • diagnosis of septic shock on intravenous vasopressors
  • stable/decreasing doses of intravenous vasopressors
  • stable/improving organ function

Exclusion Criteria:

  • allergy to midodrine
  • multiple intravenous vasopressors
  • increasing intravenous vasopressor requirements
  • worsening organ dysfunction
  • severe bradycardia

Publications:
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT02771158    
Other Study ID Numbers: temp-1187
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Northwell Health:
critical care
shock, septic
sepsis
hypotension
midodrine
Additional relevant MeSH terms:
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Shock, Septic
Hypotension
Shock
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action