Midodrine Use in Septic Shock

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03706053
• Other study ID #: 20889
• Status: Terminated
• Phase: Phase 3
• Start date: November 5, 2018
• Est. completion date: February 11, 2022

Study information

• Verified date: February 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Midodrine Hydrochloride
Midodrine Hydrochloride, enteral, 10 or 20 mg

Other:
• placebo
investigational pharmacy formulated placebo comparator

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days free of vasopressors (days)	days without vasopressor adjusted with mortality	90 days from enrollment
Secondary	Central venous catheter free days		90 days from enrollment
Secondary	Intensive care unit length of stay (ICU LOS; days)		90 days from enrollment
Secondary	Hospital length of stay (Hospital LOS; days)		90 days from enrollment
Secondary	30-day mortality		30 days from enrollment
Secondary	90-day mortality		90 days from enrollment
Secondary	In-hospital mortality	Mortality during sentinel admission	From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks
Secondary	Intensive care unit mortality	Mortality during intensive care unit stay during sentinel admission	From randomization until date of death if occurred prior to discharge from the sentinel intensive care unit admission, assessed up to 52 weeks
Secondary	Need to re-initiate IV vasopressors 2 or more hours after discontinuation		From randomization until date of discharge from the sentinel intensive care unit admission, assessed up to 52 weeks