Septic ShockPhase 3NCT03706053
Midodrine Use in Septic Shock
A Phase 3 study testing Midodrine Hydrochloride in people with Septic Shock, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Septic Shock
- What is being tested?
- Midodrine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to 11 Feb 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Midodrine Use for Hypotension Requiring IV Vasopressor Therapy in Early Septic Shock
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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Midodrine Hydrochloride, placebo
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine HydrochlorideDrug
Midodrine Hydrochloride, enteral, 10 or 20 mg
placeboOther
investigational pharmacy formulated placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) Receives: Other: placebo |
| Midodrine Hydrochloride 10 mg TID | Experimental | 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). Receives: Drug: Midodrine Hydrochloride |
| Midodrine Hydrochloride 20 mg TID | Experimental | 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). Receives: Drug: Midodrine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Free of Vasopressors (Days)
days without vasopressor adjusted with mortality
Measured: 90 days from enrollment
Secondary outcomes (8)
Central Venous Catheter Free Days
Measured: 90 days from enrollment
Intensive Care Unit Length of Stay (ICU LOS; Days)
Measured: 90 days from enrollment
Hospital Length of Stay (Hospital LOS; Days)
Measured: 90 days from enrollment
30-day Mortality
Measured: 30 days from enrollment
90-day Mortality
Measured: 90 days from enrollment
In-hospital Mortality
Mortality during sentinel admission
Measured: From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks
Intensive Care Unit Mortality
Mortality during intensive care unit stay during sentinel admission
Measured: From randomization until date of death if occurred prior to discharge from the sentinel intensive care unit admission, assessed up to 52 weeks
Need to Re-initiate IV Vasopressors 2 or More Hours After Discontinuation
Measured: From randomization until date of discharge from the sentinel intensive care unit admission, assessed up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start5 Nov 2018
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
Why it stopped: No funding for the study; not enough staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Kadl, MD, University of Virginia
- Investigators
- Alexandra Kadl, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706053
- Sponsor's protocol ID
- 20889
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2018
- Last updated
- 24 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midodrine Use for Hypotension Requiring IV Vasopressor Therapy in Early Septic Shock
- ClinicalTrials.gov ID
- NCT03706053
- Acronym / sponsor ID
- 20889
- Conditions
- Septic Shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funding for the study; not enough staff
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placeboInvestigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) |
| Midodrine Hydrochloride 10 mg TID | Experimental | Drug: Midodrine HydrochlorideIn 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). |
| Midodrine Hydrochloride 20 mg TID | Experimental | Drug: Midodrine HydrochlorideIn 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). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Midodrine HydrochlorideMidodrine Hydrochloride, enteral, 10 or 20 mg | Drug | Midodrine Hydrochloride 10 mg TID, Midodrine Hydrochloride 20 mg TID |
| placeboinvestigational pharmacy formulated placebo comparator | Other | Placebo |
Primary outcome
Days Free of Vasopressors (Days)
Time frame: 90 days from enrollment
days without vasopressor adjusted with mortality
8 secondary outcomes
Central Venous Catheter Free Days
Time frame: 90 days from enrollment
Intensive Care Unit Length of Stay (ICU LOS; Days)
Time frame: 90 days from enrollment
Hospital Length of Stay (Hospital LOS; Days)
Time frame: 90 days from enrollment
30-day Mortality
Time frame: 30 days from enrollment
90-day Mortality
Time frame: 90 days from enrollment
In-hospital Mortality
Time frame: From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alexandra Kadl, 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 Hydrochloride 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 24 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Days Free of Vasopressors (Days) (time frame: 90 days from enrollment). 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 24 Sep 2025.