Midodrine Use in Septic Shock

NCT ID: NCT03706053

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2022-02-11

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.

Detailed Description

A growing body of literature comprising largely retrospective data seems to support the safety and efficacy of midodrine in the intensive care unit for decreasing IV vasopressor use. The investigators hypothesize that administration of midodrine in the early phase of septic shock in patients with adequate enteral access will result in a significant decrease in time to IV vasopressor liberation (increase in vasopressor-free days), secondarily resulting in decreased central venous catheter dwell times and intensive care unit length of stay.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

investigational pharmacy formulated placebo comparator

Midodrine Hydrochloride 10 mg TID

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).

Group Type: EXPERIMENTAL

Midodrine Hydrochloride

Intervention Type: DRUG

Midodrine Hydrochloride, enteral, 10 or 20 mg

Midodrine Hydrochloride 20 mg TID

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).

Group Type: EXPERIMENTAL

Midodrine Hydrochloride

Intervention Type: DRUG

Midodrine Hydrochloride, enteral, 10 or 20 mg

Interventions

Midodrine Hydrochloride

Midodrine Hydrochloride, enteral, 10 or 20 mg

Intervention Type: DRUG

placebo

investigational pharmacy formulated placebo comparator

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• Non-English speaking patients, due to the narrow time-frame for study enrollment and execution of study protocol, employing interpreters is deemed to be a significant burden on the investigators with potential to hamper study enrollment. Non-english speaking patients are not deemed to be adversely affected by exclusion from study as there is no clear a priori reason why study results would not also apply to non-English speakers.
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Kadl, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra Kadl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20889

Identifier Type: -

Identifier Source: org_study_id