Midodrine in the Recovery Phase of Septic Shock

Midodrine Use in the Recovery Phase of Septic Shock

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.

Study Overview

• Status: Withdrawn
• Conditions: Septic Shock
• Intervention / Treatment: Drug: midodrine; Other: Standard of Care

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Midodrine will be given to treatment arm as enteral medication; Other Names: Midodrine Hydrochloride; Proamatine
Other: Control; 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; Patients in the control arm will receive standard of care for septic shock

What is the study measuring?

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	Time Frame
Central venous catheter free days	28 days
IV vasopressor free days	28 days
Hospital length of stay	up to 90 days

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Robert M Jones, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimated): December 13, 2016

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Adrenergic alpha-1 Receptor Agonists; Midodrine
• Other Study ID Numbers: 19198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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