Clinical trial NCT03706053: Midodrine Use in Septic Shock
Official title: Midodrine Use for Hypotension Requiring IV Vasopressor Therapy in Early Septic Shock
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Septic Shock
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: days free of vasopressors (days)
timeFrame: 90 days from enrollment
Secondary outcomes:
measure: Central venous catheter free days
timeFrame: 90 days from enrollment
measure: Intensive care unit length of stay (ICU LOS; days)
timeFrame: 90 days from enrollment
measure: Hospital length of stay (Hospital LOS; days)
timeFrame: 90 days from enrollment
measure: 30-day mortality
timeFrame: 30 days from enrollment
measure: 90-day mortality
timeFrame: 90 days from enrollment
measure: In-hospital mortality
timeFrame: From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks
measure: Intensive care unit mortality
timeFrame: From randomization until date of death if occurred prior to discharge from the sentinel intensive care unit admission, assessed up to 52 weeks
measure: Need to re-initiate IV vasopressors 2 or more hours after discontinuation
timeFrame: From randomization until date of discharge from the sentinel intensive care unit admission, assessed up to 52 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Alexandra Kadl, MD
role: PRINCIPAL_INVESTIGATOR
References: