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Midodrine in the Recovery Phase of Septic Shock

Primary Purpose

Septic Shock

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
midodrine
Standard of Care
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

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

The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal > 65 mmHg

Outcomes

Primary Outcome Measures

ICU free days
ICU free days from first 28 days

Secondary Outcome Measures

Central venous catheter free days
IV vasopressor free days
Hospital length of stay

Full Information

First Posted
November 16, 2016
Last Updated
May 2, 2018
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02990546
Brief Title
Midodrine in the Recovery Phase of Septic Shock
Official Title
Midodrine Use in the Recovery Phase of Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet enrollment goals
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2018 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

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
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Other
Arm Description
The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal > 65 mmHg
Intervention Type
Drug
Intervention Name(s)
midodrine
Other Intervention Name(s)
Midodrine Hydrochloride; Proamatine
Intervention Description
Midodrine will be given to treatment arm as enteral medication
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Patients in the control arm will receive standard of care for septic shock
Primary Outcome Measure Information:
Title
ICU free days
Description
ICU free days from first 28 days
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Central venous catheter free days
Time Frame
28 days
Title
IV vasopressor free days
Time Frame
28 days
Title
Hospital length of stay
Time Frame
up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Jones, 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
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Midodrine in the Recovery Phase of Septic Shock

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