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Midodrine Use in Septic Shock

Primary Purpose

Septic Shock

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Midodrine Hydrochloride
placebo
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Midodrine Hydrochloride 10 mg TID

Midodrine Hydrochloride 20 mg TID

Arm Description

Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group)

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).

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).

Outcomes

Primary Outcome Measures

days free of vasopressors (days)
days without vasopressor adjusted with mortality

Secondary Outcome Measures

Central venous catheter free days
Intensive care unit length of stay (ICU LOS; days)
Hospital length of stay (Hospital LOS; days)
30-day mortality
90-day mortality
In-hospital mortality
Mortality during sentinel admission
Intensive care unit mortality
Mortality during intensive care unit stay during sentinel admission
Need to re-initiate IV vasopressors 2 or more hours after discontinuation

Full Information

First Posted
September 26, 2018
Last Updated
February 17, 2022
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03706053
Brief Title
Midodrine Use in Septic Shock
Official Title
Midodrine Use for Hypotension Requiring IV Vasopressor Therapy in Early Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
No funding for the study; not enough staff
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group)
Arm Title
Midodrine Hydrochloride 10 mg TID
Arm Type
Experimental
Arm Description
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).
Arm Title
Midodrine Hydrochloride 20 mg TID
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Midodrine Hydrochloride
Intervention Description
Midodrine Hydrochloride, enteral, 10 or 20 mg
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
investigational pharmacy formulated placebo comparator
Primary Outcome Measure Information:
Title
days free of vasopressors (days)
Description
days without vasopressor adjusted with mortality
Time Frame
90 days from enrollment
Secondary Outcome Measure Information:
Title
Central venous catheter free days
Time Frame
90 days from enrollment
Title
Intensive care unit length of stay (ICU LOS; days)
Time Frame
90 days from enrollment
Title
Hospital length of stay (Hospital LOS; days)
Time Frame
90 days from enrollment
Title
30-day mortality
Time Frame
30 days from enrollment
Title
90-day mortality
Time Frame
90 days from enrollment
Title
In-hospital mortality
Description
Mortality during sentinel admission
Time Frame
From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks
Title
Intensive care unit mortality
Description
Mortality during intensive care unit stay during sentinel admission
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Kadl, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Midodrine Use in Septic Shock

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