Blood Pressure, Sepsis
Conditions
Brief summary
The investigators would like to determine if early administration of oral Midodrine in participants diagnosed with sepsis will impact blood pressures and decrease the need for and/or doses of intravenous pressor agents.
Detailed description
Three doses of either placebo or midodrine every 8 hours will be administered in addition to usual care for sepsis. The goal will be to administer the first dose approximately within 24 hours of diagnosis. The first dose will be administered only after the patient has been admitted to the ICU. Subjects will receive treatment for a total of 16 hours starting from the first dose. The medical provider, nursing staff and patient will be blinded to randomization, only research pharmacist will be aware of randomization. Blood pressure will be recorded at least on a 4 hourly basis for 24 hours from the time of administration of the first dose, and also just prior to administration of each dose. Subsequent doses will be held if systolic blood pressure, SBP, is greater than 130 mmHg. If a subject requires initiation of intravenous vasopressor agents following study enrollment, subsequent doses will be continued. There will be no further intervention after all 3 doses have been administered; however clinical outcomes and adverse events will be monitored.
Interventions
DRUGMidodrine Hydrochloride 10 milligrams
Three doses taken every 8 hours.
DRUGPlacebo capsule
Three doses taken every 8 hours.
Sponsors
Cleveland Clinic Abu Dhabi
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The medical provider, nursing staff, study coordinator and patient will be blinded to randomization, only research pharmacist will be aware of randomization.
Intervention model description
The Investigators propose a prospective, randomized, double blind, placebo-controlled pilot study on the efficacy and safety of midodrine in the treatment of sepsis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with sepsis based on the old Sepsis criteria and meeting all of the following criteria will be considered eligible to participate in the study. * Age greater than or equal to 18 years * Able to safely tolerate medication either by mouth or feeding tube (i.e. absence of nausea or vomiting) * Able to give consent for participation or have representative available * Two or more blood pressure readings taken at least 15 minutes apart with mean arterial pressures, MAPs 70 or less * Treating consultant agrees to the study plan
Exclusion criteria
Patients meeting any one of the following criteria will be excluded from participation: * Women of child bearing age with the potential to become pregnant who do not have a clinically documented negative pregnancy test * Current cardiogenic shock or known systolic heart failure with left ventricular ejection fraction (LVEF) \< 30% * Current bowel ischemia * Recent Myocardial infarction within the past 3 months * Current use of Monoamine Oxidase Inhibitors (MAOIs) * Recent Stroke within the past 3 months * Midodrine as a home medication * Known allergy to Midodrine * High dose vasopressor use (norepinephrine \>0.25 mcg/kg/min) * Lactate more than 8 mmol/L * Contraindications to use: History of pheochromocytoma or thyrotoxicosis or glaucoma or ischemic bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Vasopressor Use | 24 hours | To study the duration of vasopressor use in the first 24 hours of sepsis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial blood pressure (MAP) | 24 hours after the first drug dose | Routinely measured mean arterial blood pressure, invasive and noninvasive |
| Cumulative Fluid Balance | 24 hours after sepsis onset | To study the cumulative fluid balance during the first 24 hours of sepsis |
| ICU and hospital length of stay, central venous access use and organ failure | The first 7 days of study enrollment or until discharge | Daily Simplified Organ Failure Assessment, SOFA, scores |
| Incidence of potential side effects attributable to Midodrine | 48 hours after enrollment | To study the potential side effects attributable to Midodrine use in diagnosis of Sepsis. |
| Cumulative Vasopressor Dose | 24 hours after the first drug dose | To study the cumulative vasopressor dose requirements during the first 24 hours after study drug initiation |
Countries
United States
Outcome results
None listed