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Midodrine Use in Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706053
Recruitment Status : Unknown
Verified October 2018 by Alexandra Kadl, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : October 15, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Alexandra Kadl, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Midodrine Hydrochloride Other: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients will be randomized to intervention or placebo by the investigational pharmacy. Care providers, investigators and participants will be blinded to study arm.
Primary Purpose: Treatment
Official Title: Midodrine Use for Hypotension Requiring IV Vasopressor Therapy in Early Septic Shock
Estimated Study Start Date : October 26, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Placebo Comparator: 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)
Other: placebo
investigational pharmacy formulated placebo comparator

Experimental: 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).
Drug: Midodrine Hydrochloride
Midodrine Hydrochloride, enteral, 10 or 20 mg

Experimental: 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).
Drug: Midodrine Hydrochloride
Midodrine Hydrochloride, enteral, 10 or 20 mg




Primary Outcome Measures :
  1. days free of vasopressors (days) [ Time Frame: 90 days from enrollment ]
    days without vasopressor adjusted with mortality


Secondary Outcome Measures :
  1. Central venous catheter free days [ Time Frame: 90 days from enrollment ]
  2. Intensive care unit length of stay (ICU LOS; days) [ Time Frame: 90 days from enrollment ]
  3. Hospital length of stay (Hospital LOS; days) [ Time Frame: 90 days from enrollment ]
  4. 30-day mortality [ Time Frame: 30 days from enrollment ]
  5. 90-day mortality [ Time Frame: 90 days from enrollment ]
  6. In-hospital mortality [ Time Frame: From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks ]
    Mortality during sentinel admission

  7. Intensive care unit mortality [ Time Frame: From randomization until date of death if occurred prior to discharge from the sentinel intensive care unit admission, assessed up to 52 weeks ]
    Mortality during intensive care unit stay during sentinel admission

  8. Need to re-initiate IV vasopressors 2 or more hours after discontinuation [ Time Frame: From randomization until date of discharge from the sentinel intensive care unit admission, assessed up to 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706053


Contacts
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Contact: Alexandra Kadl, MD 434-924-0000 ak5sc@virginia.edu
Contact: Lukasz Myc, MD 434-924-0000 lam4ha@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Alexandra Kadl, MD    434-924-0000    ak5sc@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Alexandra Kadl, MD University of Virginia
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Responsible Party: Alexandra Kadl, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03706053    
Other Study ID Numbers: 20889
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action