SepsisPhase 1NCT03129542
Midodrine Hydrochloride in Early Sepsis
A Phase 1 study testing Midodrine Hydrochloride 10 milligrams in people with Sepsis and Blood Pressure, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Blood Pressure
- What is being tested?
- Midodrine Hydrochloride 10 milligrams
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 15 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Oral Midodrine Hydrochloride in Early Sepsis: Randomized, Double Blind and Placebo-Controlled Feasibility Study
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.
Read the 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.
- Conditions
- Sepsis, Blood Pressure
- Being tested
- Midodrine Hydrochloride 10 milligrams, Placebo capsule
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine Hydrochloride 10 milligramsDrug
Also called Midodrine
Three doses taken every 8 hours.
Placebo capsuleDrug
Also called Lactose Monohydrate powder
Three doses taken every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Vasopressor Use
To study the duration of vasopressor use in the first 24 hours of sepsis
Measured: 24 hours
Secondary outcomes (5)
Mean arterial blood pressure (MAP)
Routinely measured mean arterial blood pressure, invasive and noninvasive
Measured: 24 hours after the first drug dose
Cumulative Fluid Balance
To study the cumulative fluid balance during the first 24 hours of sepsis
Measured: 24 hours after sepsis onset
ICU and hospital length of stay, central venous access use and organ failure
Daily Simplified Organ Failure Assessment, SOFA, scores
Measured: The first 7 days of study enrollment or until discharge
Incidence of potential side effects attributable to Midodrine
To study the potential side effects attributable to Midodrine use in diagnosis of Sepsis.
Measured: 48 hours after enrollment
Cumulative Vasopressor Dose
To study the cumulative vasopressor dose requirements during the first 24 hours after study drug initiation
Measured: 24 hours after the first drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start30 Aug 2017
- Primary completion28 Apr 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Cleveland Clinic Abu Dhabi
- Responsible party
- Principal investigator, Ognjen Gajic, Mayo Clinic
- Investigators
- Ognjen Gajic, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129542
- Sponsor's protocol ID
- 16-002444
- Status last verified
- Feb 2021
- First submitted
- 6 Apr 2017
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Midodrine Hydrochloride in Early Sepsis: Randomized, Double Blind and Placebo-Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT03129542
- Acronym / sponsor ID
- 16-002444
- Conditions
- Sepsis, Blood Pressure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Cleveland Clinic Abu Dhabi
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Midodrine Hydrochloride 10 milligrams | Active comparator | Drug: Midodrine Hydrochloride 10 milligramsThree 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. |
| Placebo oral capsule | Placebo comparator | Drug: Placebo capsuleFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midodrine Hydrochloride 10 milligramsAlso: MidodrineThree doses taken every 8 hours. | Drug | Midodrine Hydrochloride 10 milligrams |
| Placebo capsuleAlso: Lactose Monohydrate powderThree doses taken every 8 hours. | Drug | Placebo oral capsule |
Primary outcome
Duration of Vasopressor Use
Time frame: 24 hours
To study the duration of vasopressor use in the first 24 hours of sepsis
5 secondary outcomes
Mean arterial blood pressure (MAP)
Time frame: 24 hours after the first drug dose
Cumulative Fluid Balance
Time frame: 24 hours after sepsis onset
ICU and hospital length of stay, central venous access use and organ failure
Time frame: The first 7 days of study enrollment or until discharge
Incidence of potential side effects attributable to Midodrine
Time frame: 48 hours after enrollment
Cumulative Vasopressor Dose
Time frame: 24 hours after the first drug dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ognjen Gajic principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midodrine Hydrochloride 10 milligrams in people with Sepsis and Blood Pressure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Vasopressor Use (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.