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Midodrine Hydrochloride in Early Sepsis

Primary Purpose

Sepsis, Blood Pressure

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Midodrine Hydrochloride 10 milligrams

Placebo capsule

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Midodrine Hydrochloride 10 milligrams

Placebo oral capsule

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Duration of Vasopressor Use

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

Secondary Outcome Measures

Mean arterial blood pressure (MAP)

Routinely measured mean arterial blood pressure, invasive and noninvasive

Cumulative Fluid Balance

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

Daily Simplified Organ Failure Assessment, SOFA, scores

Incidence of potential side effects attributable to Midodrine

To study the potential side effects attributable to Midodrine use in diagnosis of Sepsis.

Cumulative Vasopressor Dose

To study the cumulative vasopressor dose requirements during the first 24 hours after study drug initiation

Full Information

NCT ID

NCT03129542

First Posted

April 6, 2017

Last Updated

February 4, 2021

Sponsor

Mayo Clinic

Collaborators

Cleveland Clinic Abu Dhabi

1. Study Identification

Unique Protocol Identification Number

NCT03129542

Brief Title

Midodrine Hydrochloride in Early Sepsis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

August 30, 2017 (Actual)

Primary Completion Date

April 28, 2020 (Actual)

Study Completion Date

May 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Cleveland Clinic Abu Dhabi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Blood Pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Midodrine Hydrochloride 10 milligrams

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo oral capsule

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Midodrine Hydrochloride 10 milligrams

Other Intervention Name(s)

Midodrine

Intervention Description

Three doses taken every 8 hours.

Intervention Type

Drug

Intervention Name(s)

Placebo capsule

Other Intervention Name(s)

Lactose Monohydrate powder

Intervention Description

Three doses taken every 8 hours.

Primary Outcome Measure Information:

Title

Duration of Vasopressor Use

Description

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

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Mean arterial blood pressure (MAP)

Description

Routinely measured mean arterial blood pressure, invasive and noninvasive

Time Frame

24 hours after the first drug dose

Title

Cumulative Fluid Balance

Description

To study the cumulative fluid balance during the first 24 hours of sepsis

Time Frame

24 hours after sepsis onset

Title

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

Description

Daily Simplified Organ Failure Assessment, SOFA, scores

Time Frame

The first 7 days of study enrollment or until discharge

Title

Incidence of potential side effects attributable to Midodrine

Description

To study the potential side effects attributable to Midodrine use in diagnosis of Sepsis.

Time Frame

48 hours after enrollment

Title

Cumulative Vasopressor Dose

Description

To study the cumulative vasopressor dose requirements during the first 24 hours after study drug initiation

Time Frame

24 hours after the first drug dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ognjen Gajic

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

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Midodrine Hydrochloride in Early Sepsis

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