Midodrine During Recovery From Septic Shock

Study Overview
=================
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.

Official Title
-----------------
A Randomized Controlled Trial of Midodrine During Recovery Phase From Septic Shock

Conditions
-----------------
Hypotension, Shock, Septic, Sepsis

Intervention / Treatment
-----------------
* Drug: Midodrine
* Drug: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: midodrine<br>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<br>* 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<br>* Other names: proamatine;|
| Placebo Comparator: placebo<br>randomization to placebo control | Drug: placebo<br>* placebo will be administered to double blind the study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of intravenous vasopressors |  | from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensive care unit length of stay |  | from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days | 
| re-institution of intravenous vasopressor |  | from enrollment until hospital discharge, expected to be up to 30 days | 
| hospital length of stay |  | from enrollment until hospital discharge, expected to be up to 30 days | 
| mortality |  | from enrollment until hospital discharge, expected to be up to 30 days | 
| midodrine side effects requiring discontinuation | including supine hypertension and bradycardia | from enrollment until hospital discharge, expected to be up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical care, shock, septic, sepsis, hypotension, midodrine