Low Blood Pressure, Sepsis
Conditions
Keywords
Vasopressors
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.
Interventions
DRUGMidodrine
Subjects will receive standard of care for sepsis and 10 mg of Midodrine every 8 hours administered orally or enterally (via nasogastric tube)
OTHERStandard of Care
Subjects will receive standard of care for sepsis treatment.
Sponsors
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time alive and without vasopressor support | 28 days | Measured in hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total vasopressor requirements | 28 days | Measured as norepinephrine equivalents (µg) |
| Central venous access duration | 28 days | Measured in hours |
| Cumulative fluid balance over the first 48 hours | 48 hours | — |
| Cumulative fluid balance up to 7 days of ICU stay | 7 days | — |
| ICU Length of Stay | 28 days | Total number of days admitted to the Intensive Care Unit (ICU) |
| Hospital Length of Stay | 28 days | Total number of days admitted to the hospital |
| ICU, hospital, and organ support-free days | 28 days | Number of ICU, hospital, and organ support-free days |
Countries
United States
Contacts
CONTACTAva Beetcher
CONTACTAysun Tekin, MD, MS
PRINCIPAL_INVESTIGATORAmos Lal, MBBS
Mayo Clinic
PRINCIPAL_INVESTIGATOROgnjen Gajic, MD
Mayo Clinic
Outcome results
None listed