Trial Outcomes & Findings for Midodrine Use in Septic Shock (NCT NCT03706053)

NCT ID: NCT03706053

Last Updated: 2025-09-24

Results Overview

days without vasopressor adjusted with mortality

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: 90 days from enrollment
• Results posted on: 2025-09-24

Participant Flow

Participant milestones

Measure	Placebo Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
Overall Study STARTED	3	4	3
Overall Study COMPLETED	3	4	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Midodrine Use in Septic Shock

Baseline characteristics by cohort

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Age, Continuous	65 years n=5 Participants	65.5 years n=7 Participants	62.33 years n=5 Participants	65.4 years n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: 90 days from enrollment

days without vasopressor adjusted with mortality

Outcome measures

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
Days Free of Vasopressors (Days)	24.3 days Interval 24.0 to 25.0	7.5 days Interval 0.0 to 27.0	25.6 days Interval 24.0 to 27.0

SECONDARY outcome

Timeframe: 90 days from enrollment

Outcome measures

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
Central Venous Catheter Free Days	15.3 days Interval 0.0 to 23.0	7.25 days Interval 0.0 to 28.0	25 days Interval 23.0 to 28.0

SECONDARY outcome

Timeframe: 90 days from enrollment

Outcome measures

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
Intensive Care Unit Length of Stay (ICU LOS; Days)	6 days Interval 5.0 to 7.0	10 days Interval 1.0 to 23.0	7.6 days Interval 5.0 to 10.0

SECONDARY outcome

Timeframe: 90 days from enrollment

Outcome measures

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
Hospital Length of Stay (Hospital LOS; Days)	11.3 days Interval 8.0 to 17.0	11 days Interval 1.0 to 23.0	15.7 days Interval 10.0 to 26.0

SECONDARY outcome

Timeframe: 30 days from enrollment

Outcome measures

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
30-day Mortality	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 90 days from enrollment

Outcome measures

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
90-day Mortality	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks

Mortality during sentinel admission

Outcome measures

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
In-hospital Mortality	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization until date of death if occurred prior to discharge from the sentinel intensive care unit admission, assessed up to 52 weeks

Mortality during intensive care unit stay during sentinel admission

Outcome measures

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
Intensive Care Unit Mortality	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization until date of discharge from the sentinel intensive care unit admission, assessed up to 52 weeks

Outcome measures

Measure	Placebo n=3 Participants Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) placebo: investigational pharmacy formulated placebo comparator	Midodrine Hydrochloride 10 mg TID n=4 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg	Midodrine Hydrochloride 20 mg TID n=3 Participants In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group). After the first 45 patients are enrolled, interim safety and efficacy analysis will dictate which experimental group is continued/open to further enrollment (either 10 mg midodrine TID or 20 mg midodrine TID). Midodrine Hydrochloride: Midodrine Hydrochloride, enteral, 10 or 20 mg
Need to Re-initiate IV Vasopressors 2 or More Hours After Discontinuation	2 participants	0 participants	0 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Midodrine Hydrochloride 10 mg TID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Midodrine Hydrochloride 20 mg TID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alex Kadl

UVA Health

Phone: 434-243-4851

Email: AK5SC@uvahealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place