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The aim of this study is to investigate the role of oral midodrine in the recovery of septic shock. The investigators hypothesize that the oral drug can reduce central line days and ICU length of stay.
The investigators aim to investigate the use of midodrine in the recovery phase of septic shock in a randomized control trial. The investigators hypothesize that midodrine use initiated after stabilization or improving intravenous vasopressor requirement will lead to decreased length of ICU stay and length of time that intravenous vasopressors are required.
The investigators plan to enroll and consent patients at the onset of septic shock. Once IV vasopressor requirement is stabilized or decreasing, males and females will be randomized in 1:1 fashion to receive either standard clinical care or standard clinical care plus oral midodrine. The investigators will analyze length of stay in the ICU, time on vasopressors, time needing a central line, and hospital length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | In the intervention arm 10 mg of midodrine will be given orally three times daily starting at the time of stable or decreasing intravenous vasopressor support |
|
| Control | Other | The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal > 65 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midodrine | Drug | Midodrine will be given to treatment arm as enteral medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| ICU free days | ICU free days from first 28 days | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Central venous catheter free days | 28 days | |
| IV vasopressor free days | 28 days | |
| Hospital length of stay |
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Inclusion Criteria:
• Patients aged 18-99 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Jones, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Standard of Care | Other | Patients in the control arm will receive standard of care for septic shock |
|
| up to 90 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D000588 |
| Amines |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |