Midodrine Use in Septic Shock

• Status: Unknown status
• Trial end date: 2020-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Virginia
• Treatments: Midodrine

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