Midodrine Hydrochloride in Early Sepsis

Sepsis Clinical Trial

Official title:

Oral Midodrine Hydrochloride in Early Sepsis: Randomized, Double Blind and Placebo-Controlled Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129542
• Other study ID #: 16-002444
• Status: Completed
• Phase: Phase 1
• Start date: August 30, 2017
• Est. completion date: May 15, 2020

Study information

• Verified date: February 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 15, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Sepsis
• Toxemia

Intervention

Drug:
• Midodrine Hydrochloride 10 milligrams
Three doses taken every 8 hours.
• Placebo capsule
Three doses taken every 8 hours.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Cleveland Clinic Abu Dhabi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Vasopressor Use	To study the duration of vasopressor use in the first 24 hours of sepsis	24 hours
Secondary	Mean arterial blood pressure (MAP)	Routinely measured mean arterial blood pressure, invasive and noninvasive	24 hours after the first drug dose
Secondary	Cumulative Fluid Balance	To study the cumulative fluid balance during the first 24 hours of sepsis	24 hours after sepsis onset
Secondary	ICU and hospital length of stay, central venous access use and organ failure	Daily Simplified Organ Failure Assessment, SOFA, scores	The first 7 days of study enrollment or until discharge
Secondary	Incidence of potential side effects attributable to Midodrine	To study the potential side effects attributable to Midodrine use in diagnosis of Sepsis.	48 hours after enrollment
Secondary	Cumulative Vasopressor Dose	To study the cumulative vasopressor dose requirements during the first 24 hours after study drug initiation	24 hours after the first drug dose

External Links

•   Mayo Clinic Clinical Trials