Could a simple pill help sepsis patients leave the ICU sooner?
NCT ID NCT06319248
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This study tests whether giving the oral drug midodrine early to sepsis patients with low blood pressure can help them stop needing IV blood-pressure medications sooner. Researchers will compare standard care plus midodrine to standard care alone in 308 adults. The goal is to see if this approach shortens time on IV drugs, reduces hospital stays, and makes recovery smoother.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Midodrine (a blood-pressure-raising drug taken by mouth or feeding tube)
- What this could lead to
- If it works, this could offer a simpler way to wean sepsis patients off IV blood-pressure medications, leading to shorter hospital stays and fewer complications from tubes.
- What could go wrong
- This is a mid-stage trial with 308 participants, so results are not yet proven. Midodrine may not reduce IV vasopressor use or could cause side effects like high blood pressure or skin reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 308 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: Patients diagnosed with sepsis within 24 hours of meeting all of the following criteria will be eligible to participate in the study: * Sepsis-3 criteria: acute hospital admission for suspected infection with new or worsening organ dysfunction measured by the increase in Sequential Organ failure Assessment (SOFA) score of 2 points or more. * IV vasopressor use or persistent hypotension (MAP \< 65 mm Hg) after initial fluid resuscitation in the ED or ICU (30 mL/kg unless deemed excessive by the treating clinician). Exclusion criteria: * High-dose vasopressors (norepinephrine equivalent \> 0.3 μg/kg/min) * Inadequately controlled source of infection * Cardiogenic or obstructive (massive pulmonary embolism) shock * Clinical suspicion or confirmed diagnosis of bowel obstruction, bowel ischemia, or ileus * Contraindication to enteral intake (ileus, vomiting, gastrointestinal bleeding, endoscopic procedures etc.) * Recent myocardial infarction (STEMI or NSTEMI Type 1 within the past 3 months) * Recent treatment for peripheral vascular disease (within the past 3 months) or acute limb ischemia * Current use of monoamine oxidase inhibitors * Recent stroke (within the past 3 months) * Prior use of midodrine as a home medication * Known allergy to midodrine * Comfort care measures * Pregnancy * Bradycardia (heart rate \< 50 beats/min) * Untreated pheochromocytoma * Untreated thyrotoxicosis * Acute Angle-Closure Glaucoma * Cirrhosis or liver failure with Child-Pugh Score \> 12 * Venous blood lactate \> 4 * Treating emergency or critical care physician unwilling to enroll patient in trial * Inability to give consent for participation and no representative or surrogate available to consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic Arizona
RECRUITINGScottsdale, Arizona, 85259, United States
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Mayo Clinic Florida
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic Health System - Eau Claire
RECRUITINGEau Claire, Wisconsin, 54703, United States
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Mayo Clinic Health System - Mankato
RECRUITINGMankato, Minnesota, 56001, United States
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Mayo Clinic Minnesota
RECRUITINGRochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a computer model speed up sepsis blood tests?
- Stem cells put to the test against Sepsis's immune chaos
- Can the immune system reveal who will suffer kidney injury after sepsis?
- A routine calcium reading could reveal how sick a sepsis patient really is