A Phase 1 interventional study of Midodrine Hydrochloride 10 milligrams and Placebo capsule in Sepsis and Blood Pressure, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
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.
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.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's enrollment of 33 is below the median of 105 across 918 interventional studies indexed under Sepsis.
Browse Sepsis studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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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.
Exclusion Criteria:
Patients meeting any one of the following criteria will be excluded from participation:
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
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
Three doses taken every 8 hours.
Also known as: Midodrine
Three doses taken every 8 hours.
Also known as: Lactose Monohydrate powder
Duration of Vasopressor Use
To study the duration of vasopressor use in the first 24 hours of sepsis
Time frame: 24 hours
Mean arterial blood pressure (MAP)
Routinely measured mean arterial blood pressure, invasive and noninvasive
Time frame: 24 hours after the first drug dose
Cumulative Fluid Balance
To study the cumulative fluid balance during the first 24 hours of sepsis
Time frame: 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
Time frame: 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.
Time frame: 48 hours after enrollment
Cumulative Vasopressor Dose
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
Plan to share: No
Ran from Aug 2017 to primary completion in Apr 2020, 31 months.
Of 26 phase 1 interventional studies under Sepsis, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's 31 months is above that.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midodrine