Midodrine During Recovery From Septic Shock

Northwell Health

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Conditions

Hypotension Shock, Septic Sepsis

Interventions

MidodrineDRUG

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

placeboDRUG

placebo will be administered to double blind the study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

duration of intravenous vasopressors

Time frame: from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days

Secondary Outcomes

intensive care unit length of stay

Time frame: from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days

re-institution of intravenous vasopressor

Time frame: from enrollment until hospital discharge, expected to be up to 30 days

hospital length of stay

Time frame: from enrollment until hospital discharge, expected to be up to 30 days

mortality

Time frame: from enrollment until hospital discharge, expected to be up to 30 days

midodrine side effects requiring discontinuation

including supine hypertension and bradycardia

Time frame: from enrollment until hospital discharge, expected to be up to 30 days

Data from ClinicalTrials.gov

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