Use of Midodrine in Septic Shock Patients

Sepsis Clinical Trial

Official title:

Use of Midodrine in Septic Shock Patients: Phase II Randomized Clinical Meta-trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319248
• Other study ID #: 24-000121
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 12, 2024
• Est. completion date: July 30, 2029

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: July 30, 2029
• Est. primary completion date: May 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Low Blood Pressure
• Sepsis

Intervention

Drug:
• Midodrine
10 mg every 8 hours administered orally or enterally (via nasogastric tube)
• Placebo
Looks and administered exactly like the study drug, but it contains no active ingredient

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time alive and without vasopressor support	Measured in hours	28 days
Secondary	Total vasopressor requirements	Measured as norepinephrine equivalents (µg)	28 days
Secondary	Central venous access duration	Measured in hours	28 days
Secondary	Cumulative fluid balance over the first 48 hours		48 hours
Secondary	Cumulative fluid balance up to 7 days of ICU stay		7 days
Secondary	ICU Length of Stay	Total number of days admitted to the Intensive Care Unit (ICU)	28 days
Secondary	Hospital Length of Stay	Total number of days admitted to the hospital	28 days
Secondary	ICU, hospital, and organ support-free days	Number of ICU, hospital, and organ support-free days	28 days