NCT03706053

Midodrine Use in Septic Shock

Midodrine Use for Hypotension Requiring IV Vasopressor Therapy in Early Septic Shock

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Midodrine Hydrochloride	Midodrine Hydrochloride, enteral, 10 or 20 mg
OTHER	placebo	investigational pharmacy formulated placebo comparator

Timeline

• Start date: 2018-11-05
• Primary completion: 2022-02-11
• Completion: 2022-02-11
• First posted: 2018-10-15
• Last updated: 2025-09-24
• Results posted: 2025-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study