Midodrine Hydrochloride in Early Sepsis

NCT03129542 | Completed Phase 1 FDA Drug

• 1 other identifier: 16-002444
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Duration of Vasopressor Use

  To study the duration of vasopressor use in the first 24 hours of sepsis

  24 hours

Secondary Outcomes (5)

• Mean arterial blood pressure (MAP)

  24 hours after the first drug dose

• Cumulative Fluid Balance

  24 hours after sepsis onset

• ICU and hospital length of stay, central venous access use and organ failure

  The first 7 days of study enrollment or until discharge

• Incidence of potential side effects attributable to Midodrine

  48 hours after enrollment

• Cumulative Vasopressor Dose

  24 hours after the first drug dose

Study Arms (2)

Midodrine Hydrochloride 10 milligrams

ACTIVE COMPARATOR

Three doses of oral midodrine every 8 hours will be administered in addition to usual care for sepsis. Participants randomized to the intervention group will receive a total of 3 doses of midodrine 10 milligrams every 8 hours by mouth in the form of a tablet encapsulated in order to be identical to placebo. Participants will receive treatment for a total of 16 hours, beginning with the first dose.

Drug: Midodrine Hydrochloride 10 milligrams

Placebo oral capsule

PLACEBO COMPARATOR

For participants randomized to the placebo arm, an identical appearing capsule containing only Lactose Monohydrate powder will be administered every 8 hours for a total of 3 doses.

Drug: Placebo capsule

Interventions

Midodrine Hydrochloride 10 milligrams DRUG

Three doses taken every 8 hours.

Also known as: Midodrine

Midodrine Hydrochloride 10 milligrams

Placebo capsule DRUG

Three doses taken every 8 hours.

Also known as: Lactose Monohydrate powder

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Cleveland Clinic Abu Dhabi: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sepsis

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Ognjen Gajic

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The medical provider, nursing staff, study coordinator and patient will be blinded to randomization, only research pharmacist will be aware of randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The Investigators propose a prospective, randomized, double blind, placebo-controlled pilot study on the efficacy and safety of midodrine in the treatment of sepsis.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 26, 2017
• Study Start: August 30, 2017
• Primary Completion: April 28, 2020
• Study Completion: May 15, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)