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Midodrine During Recovery From Septic Shock

NCT ID: NCT02771158

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2017-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypotension Shock, Septic Sepsis

Keywords

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critical care shock, septic sepsis hypotension midodrine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Midodrine

Intervention Type DRUG

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

placebo

randomization to placebo control

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo will be administered to double blind the study

Interventions

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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

Intervention Type DRUG

placebo

placebo will be administered to double blind the study

Intervention Type DRUG

Other Intervention Names

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proamatine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.

Reference Type BACKGROUND
PMID: 26953217 (View on PubMed)

Other Identifiers

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temp-1187

Identifier Type: -

Identifier Source: org_study_id