Midodrine in the Recovery Phase of Septic Shock

Study Overview
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Brief Summary
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The aim of this study is to investigate the role of oral midodrine in the recovery of septic shock. The investigators hypothesize that the oral drug can reduce central line days and ICU length of stay.

Detailed Description
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The investigators aim to investigate the use of midodrine in the recovery phase of septic shock in a randomized control trial. The investigators hypothesize that midodrine use initiated after stabilization or improving intravenous vasopressor requirement will lead to decreased length of ICU stay and length of time that intravenous vasopressors are required. The investigators plan to enroll and consent patients at the onset of septic shock. Once IV vasopressor requirement is stabilized or decreasing, males and females will be randomized in 1:1 fashion to receive either standard clinical care or standard clinical care plus oral midodrine. The investigators will analyze length of stay in the ICU, time on vasopressors, time needing a central line, and hospital length of stay.

Official Title
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Midodrine Use in the Recovery Phase of Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: midodrine
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients aged 18-99 years old Admitted to UVA medical ICU with diagnosis of septic shock. Exclusion Criteria: Pregnant females, patients with childbearing potential will have urine pregnancy testing after consent Patients < 18 years Prisoners Patients already taking midodrine Patients with cirrhosis and Child-Pugh Class C (Child-Pugh score > 9)_ Patients with Increased intraocular pressure and glaucoma Patients with allergy to midodrine Non-English speaking patients Patients without enteral access Patients where the attending physician does not feel MAP goal of > 65 mmHg is physiologically acceptable.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>In the intervention arm 10 mg of midodrine will be given orally three times daily starting at the time of stable or decreasing intravenous vasopressor support | Drug: midodrine<br>* Midodrine will be given to treatment arm as enteral medication<br>* Other names: Midodrine Hydrochloride; Proamatine;|
| Other: Control<br>The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal > 65 mmHg | Other: Standard of Care<br>* Patients in the control arm will receive standard of care for septic shock<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU free days | ICU free days from first 28 days | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central venous catheter free days |  | 28 days | 
| IV vasopressor free days |  | 28 days | 
| Hospital length of stay |  | up to 90 days |