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Midodrine in the Recovery Phase of Septic Shock

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ClinicalTrials.gov Identifier: NCT02990546
Recruitment Status : Terminated (Unable to meet enrollment goals)
First Posted : December 13, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Jones, MD, University of Virginia

Brief Summary:
The aim of this study is to investigate the role of oral midodrine in the recovery of septic shock. The investigators hypothesize that the oral drug can reduce central line days and ICU length of stay.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: midodrine Other: Standard of Care Phase 3

Detailed Description:

The investigators aim to investigate the use of midodrine in the recovery phase of septic shock in a randomized control trial. The investigators hypothesize that midodrine use initiated after stabilization or improving intravenous vasopressor requirement will lead to decreased length of ICU stay and length of time that intravenous vasopressors are required.

The investigators plan to enroll and consent patients at the onset of septic shock. Once IV vasopressor requirement is stabilized or decreasing, males and females will be randomized in 1:1 fashion to receive either standard clinical care or standard clinical care plus oral midodrine. The investigators will analyze length of stay in the ICU, time on vasopressors, time needing a central line, and hospital length of stay.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Midodrine Use in the Recovery Phase of Septic Shock
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 2, 2018
Actual Study Completion Date : May 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Intervention
In the intervention arm 10 mg of midodrine will be given orally three times daily starting at the time of stable or decreasing intravenous vasopressor support
Drug: midodrine
Midodrine will be given to treatment arm as enteral medication
Other Name: Midodrine Hydrochloride; Proamatine

Control
The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal > 65 mmHg
Other: Standard of Care
Patients in the control arm will receive standard of care for septic shock




Primary Outcome Measures :
  1. ICU free days [ Time Frame: 28 days ]
    ICU free days from first 28 days


Secondary Outcome Measures :
  1. Central venous catheter free days [ Time Frame: 28 days ]
  2. IV vasopressor free days [ Time Frame: 28 days ]
  3. Hospital length of stay [ Time Frame: up to 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Patients aged 18-99 years old

    • Admitted to UVA medical ICU with diagnosis of septic shock.

Exclusion Criteria:

  • Pregnant females, patients with childbearing potential will have urine pregnancy testing after consent
  • Patients < 18 years
  • Prisoners
  • Patients already taking midodrine
  • Patients with cirrhosis and Child-Pugh Class C (Child-Pugh score > 9)_
  • Patients with Increased intraocular pressure and glaucoma
  • Patients with allergy to midodrine
  • Non-English speaking patients
  • Patients without enteral access
  • Patients where the attending physician does not feel MAP goal of > 65 mmHg is physiologically acceptable.

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): NCT02990546


Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Robert M Jones, MD University of Virginia
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Responsible Party: Robert Jones, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT02990546    
Other Study ID Numbers: 19198
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 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
Product Manufactured in and Exported from the U.S.: 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