Use of Midodrine in Septic Shock Patients

Launched by MAYO CLINIC · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called Midodrine can help patients with septic shock, a serious condition caused by infections that can lead to dangerously low blood pressure. The goal is to see if giving Midodrine early on can help maintain a higher blood pressure without relying as much on intravenous medications (IV drugs), which could lead to shorter hospital stays and a more comfortable recovery process for patients.

To participate in this study, patients need to be diagnosed with sepsis within 24 hours and have certain symptoms, such as low blood pressure despite receiving fluids. However, not everyone can join; for example, patients who are already on high doses of other blood pressure medications or have specific health issues like recent heart problems or certain types of shock will not be eligible. If chosen to participate, patients will receive Midodrine and be monitored closely to see how it affects their recovery. This trial is currently looking for participants aged 65 to 74, and both men and women can join.

Gender

ALL

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.