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No funding for the study; not enough staff
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The investigators aim to perform a randomized, double-blind, placebo-controlled trial to investigate the efficacy of midodrine in decreasing time to IV vasopressor liberation in patients with septic shock.
A growing body of literature comprising largely retrospective data seems to support the safety and efficacy of midodrine in the intensive care unit for decreasing IV vasopressor use. The investigators hypothesize that administration of midodrine in the early phase of septic shock in patients with adequate enteral access will result in a significant decrease in time to IV vasopressor liberation (increase in vasopressor-free days), secondarily resulting in decreased central venous catheter dwell times and intensive care unit length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Investigational pharmacy formulated placebo. In early phase patients will be randomized to placebo, 10mg TID midodrine or 20 mg TID midodrine. (15 per group) |
|
| Midodrine Hydrochloride 10 mg TID | Experimental | 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 20 mg TID | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine Hydrochloride | Drug | Midodrine Hydrochloride, enteral, 10 or 20 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days Free of Vasopressors (Days) | days without vasopressor adjusted with mortality | 90 days from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Central Venous Catheter Free Days | 90 days from enrollment | |
| Intensive Care Unit Length of Stay (ICU LOS; Days) | 90 days from enrollment | |
| Hospital Length of Stay (Hospital LOS; Days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Kadl, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Midodrine Hydrochloride 10 mg TID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Days Free of Vasopressors (Days) | days without vasopressor adjusted with mortality | Posted | Mean | Full Range | days | 90 days from enrollment |
|
Adverse event data were collected for 30 days. All-Cause Mortality was assessed from randomization until date of discharge from the sentinel intensive care unit admission, up to 52 weeks.
Adverse event data were collected for 30 days. All-Cause Mortality was assessed from randomization until date of discharge from the sentinel intensive care unit admission, with follow-up for up to 52 weeks. Two subjects died in the ICU. One additional subject died within 30 days of ICU admission but had been discharged prior.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alex Kadl | UVA Health | 434-243-4851 | AK5SC@uvahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2018 | Mar 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2018 | Mar 12, 2024 | ICF_001.pdf |
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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 |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Patients will be randomized to intervention or placebo by the investigational pharmacy. Care providers, investigators and participants will be blinded to study arm.
| placebo | Other | investigational pharmacy formulated placebo comparator |
|
| 90 days from enrollment |
| 30-day Mortality | 30 days from enrollment |
| 90-day Mortality | 90 days from enrollment |
| In-hospital Mortality | Mortality during sentinel admission | From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks |
| Intensive Care Unit Mortality | Mortality during intensive care unit stay during sentinel admission | From randomization until date of death if occurred prior to discharge from the sentinel intensive care unit admission, assessed up to 52 weeks |
| Need to Re-initiate IV Vasopressors 2 or More Hours After Discontinuation | From randomization until date of discharge from the sentinel intensive care unit admission, assessed up to 52 weeks |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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 |
|
|
| Secondary | Central Venous Catheter Free Days | Posted | Mean | Full Range | days | 90 days from enrollment |
|
|
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| Secondary | Intensive Care Unit Length of Stay (ICU LOS; Days) | Posted | Mean | Full Range | days | 90 days from enrollment |
|
|
|
| Secondary | Hospital Length of Stay (Hospital LOS; Days) | Posted | Mean | Full Range | days | 90 days from enrollment |
|
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| Secondary | 30-day Mortality | Posted | Count of Participants | Participants | 30 days from enrollment |
|
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| Secondary | 90-day Mortality | Posted | Count of Participants | Participants | 90 days from enrollment |
|
|
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| Secondary | In-hospital Mortality | Mortality during sentinel admission | Posted | Count of Participants | Participants | From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks |
|
|
|
| Secondary | Intensive Care Unit Mortality | Mortality during intensive care unit stay during sentinel admission | Posted | Count of Participants | Participants | From randomization until date of death if occurred prior to discharge from the sentinel intensive care unit admission, assessed up to 52 weeks |
|
|
|
| Secondary | Need to Re-initiate IV Vasopressors 2 or More Hours After Discontinuation | Posted | Number | participants | From randomization until date of discharge from the sentinel intensive care unit admission, assessed up to 52 weeks |
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|
| 2 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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 | 1 | 4 | 0 | 4 | 0 | 4 |
| EG002 | 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 | 0 | 3 | 0 | 3 | 0 | 3 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D000588 |
| Amines |