Midodrine Use in Septic Shock

NCT03706053 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 20889
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to perform a randomized, double-blind, placebo-controlled trial to investigate the efficacy of midodrine in decreasing time to IV vasopressor liberation in patients with septic shock.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Days Free of Vasopressors (Days)

  days without vasopressor adjusted with mortality

  90 days from enrollment

Secondary Outcomes (8)

• Central Venous Catheter Free Days

  90 days from enrollment

• Intensive Care Unit Length of Stay (ICU LOS; Days)

  90 days from enrollment

• Hospital Length of Stay (Hospital LOS; Days)

  90 days from enrollment

• 30-day Mortality

  30 days from enrollment

• 90-day Mortality

  90 days from enrollment

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group)

Other: placebo

Midodrine Hydrochloride 10 mg TID

EXPERIMENTAL

In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID).

Drug: Midodrine Hydrochloride

Midodrine Hydrochloride 20 mg TID

EXPERIMENTAL

In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID).

Drug: Midodrine Hydrochloride

Interventions

Midodrine Hydrochloride DRUG

Midodrine Hydrochloride, enteral, 10 or 20 mg

Midodrine Hydrochloride 10 mg TID; Midodrine Hydrochloride 20 mg TID

placebo OTHER

investigational pharmacy formulated placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18-89 years old
• Admitted to UVA medical ICU with diagnosis of septic shock.
• Patients requiring at least 5 mcg/min norepinephrine infusion (or equivalent) for blood pressure support for at least 3 hours
• Patients with enteral access established within 12 hours of admission (either able to swallow, or feeding tube in place)

You may not qualify if:

• Pregnant females; (due to the potential adverse effects to an unborn child); patients with childbearing potential will have results of pregnancy test checked (which is routinely performed on admission); should the patient have child-bearing potential and the pregnancy status is not checked as part of routine care, such patients will be excluded from the study (i.e. pregnancy testing will not be performed for research purposes)
• Patients \< 18 years
• Prisoners
• Patients already taking midodrine
• Patients with cirrhosis of the liver as defined by either biopsy, imaging findings of cirrhosis AND thrombocytopenia or patients otherwise undergoing liver transplant evaluation
• Patients with Increased intraocular pressure and glaucoma
• Patients with allergy to midodrine
• Patients without enteral access within 12 hours of initiation of IV vasopressors
• Patients where the attending physician does not clinically intend to target a mean arterial pressure of \> 65 mmHg
• Patients with pheochromocytoma or thyrotoxicosis
• Patients with active bowel ischemia

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dr. Alex Kadl
• Organization: UVA Health

AK5SC@uvahealth.org

434-243-4851

Study Officials

• Alexandra Kadl, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients will be randomized to intervention or placebo by the investigational pharmacy. Care providers, investigators and participants will be blinded to study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 15, 2018
• Study Start: November 5, 2018
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)