Clinical trial NCT06319248: Use of Midodrine in Septic Shock Patients
Official title: Use of Midodrine in Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Sepsis
Low Blood Pressure
Keywords: Vasopressors
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. Researchers want to see if Midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall.


Eligibility criteria: 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 (within the past 3 months).
* Recent treatment for peripheral vascular disease (within the past 3 months).
* 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.
* Fludrocortisone acetate as a current home medication.
* Bradycardia (heart rate \< 50 beats/min).
* Untreated pheochromocytoma.
* Untreated thyrotoxicosis.
* Open-angle glaucoma.
* 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.

Primary outcomes:
measure: Time alive and without vasopressor support
timeFrame: 28 days
Secondary outcomes:
measure: Total vasopressor requirements
timeFrame: 28 days
measure: Central venous access duration
timeFrame: 28 days
measure: Cumulative fluid balance over the first 48 hours
timeFrame: 48 hours
measure: Cumulative fluid balance up to 7 days of ICU stay
timeFrame: 7 days
measure: ICU Length of Stay
timeFrame: 28 days
measure: Hospital Length of Stay
timeFrame: 28 days
measure: ICU, hospital, and organ support-free days
timeFrame: 28 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amos Lal, MBBS
role: PRINCIPAL_INVESTIGATOR
References: