Septic ShockPhase 3NCT02990546
Midodrine in the Recovery Phase of Septic Shock
A Phase 3 study testing midodrine in people with Septic Shock, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- midodrine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 2 May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients aged 18-99 years old
- Admitted to UVA medical ICU with diagnosis of septic shock.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Midodrine Use in the Recovery Phase of Septic Shock
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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- midodrine, Standard of Care
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midodrineDrug
Also called Midodrine Hydrochloride; Proamatine
Midodrine will be given to treatment arm as enteral medication
Standard of CareOther
Patients in the control arm will receive standard of care for septic shock
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Drug: midodrine |
| Control | Other | The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal > 65 mmHg Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU free days
ICU free days from first 28 days
Measured: 28 days
Secondary outcomes (3)
Central venous catheter free days
Measured: 28 days
IV vasopressor free days
Measured: 28 days
Hospital length of stay
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion2 May 2018
- Study completion2 May 2018
Why it stopped: Unable to enroll subjects before PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert M Jones, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990546
- Sponsor's protocol ID
- 19198
- Status last verified
- Jan 2024
- First submitted
- 16 Nov 2016
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midodrine Use in the Recovery Phase of Septic Shock
- ClinicalTrials.gov ID
- NCT02990546
- Acronym / sponsor ID
- 19198
- Conditions
- Septic Shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll subjects before PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: midodrineIn 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 |
| Control | Other | Other: Standard of CareThe control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal > 65 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Patients aged 18-99 years old
Key exclusion criteria (10 listed)
- 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)_
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midodrineAlso: Midodrine Hydrochloride; ProamatineMidodrine will be given to treatment arm as enteral medication | Drug | Intervention |
| Standard of CarePatients in the control arm will receive standard of care for septic shock | Other | Control |
Primary outcome
ICU free days
Time frame: 28 days
ICU free days from first 28 days
3 secondary outcomes
Central venous catheter free days
Time frame: 28 days
IV vasopressor free days
Time frame: 28 days
Hospital length of stay
Time frame: up to 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Jones, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing midodrine in people with Septic Shock, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU free days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.