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Retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing in septic shock
This will be a retrospective four-cohort study. The four cohorts will be septic shock patients that were: 1) not on either a chronic β-blocker or chronic angiotensin-converting-enzyme inhibitor (ACE-Inhibitor), 2) on chronic β-blocker, 3) on ACE-Inhibitor, and 4) on both chronic β-blocker and ACE-inhibitor
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No chronic antihypertensives | not on either a chronic β-blocker or ACE-Inhibitor | ||
| β-blocker | on chronic β-blocker | ||
| ACE-Inhibitor | on chronic ACE-Inhibitor | ||
| Both β-blocker and ACE-inhibitor | on both chronic β-blocker and ACE-inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Vasopressor Dose | The primary objective is to determine the effect of chronic β-blocker or ACE-inhibitor on vasopressor dosing in the first 48 hours of septic shock. Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 30 mL/kg Fluid Within 6h | Number of Participants with 30 mL/kg Fluid Within 6 Hours | 48 hours |
| Inotrope Use | Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone |
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Inclusion Criteria:
Exclusion Criteria:
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Adult, non-pregnant medical intensive care unite (MICU) patients with septic shock requiring vasopressor support
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| Name | Affiliation | Role |
|---|---|---|
| Joshua DeMott, Pharm.D. | Rush University Medical Center | Principal Investigator |
| Ishaq Lat, Pharm.D. | Rush University Medical Center | Principal Investigator |
| Gourang Patel, Pharm.D. | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush Univeristy Medical Center | Chicago | Illinois | 60612 | United States |
To be determined
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retrospective study
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| ID | Title | Description |
|---|---|---|
| FG000 | No Chronic Antihypertensives | not on either a chronic β-blocker or ACE-Inhibitor |
| FG001 | β-blocker | on chronic β-blocker |
| FG002 | ACE-Inhibitor | on chronic ACE-Inhibitor |
| FG003 | Both β-blocker and ACE-inhibitor | on both chronic β-blocker and ACE-inhibitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Chronic Antihypertensives | not on either a chronic β-blocker or ACE-Inhibitor |
| BG001 | β-blocker | on chronic β-blocker |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Total Vasopressor Dose | The primary objective is to determine the effect of chronic β-blocker or ACE-inhibitor on vasopressor dosing in the first 48 hours of septic shock. Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | Posted | Median | Inter-Quartile Range | mg | 48 hours |
|
During the inpatient hospital stay, up to 48 hours
inpatient mortality
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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 | No Chronic Antihypertensives | not on either a chronic β-blocker or ACE-Inhibitor |
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Adherence to prescribed chronic β-blockers or ACE inhibitors could not be confirmed. The electronic medical record charting by the staff may be subject to inaccuracies in vasopressor dose infusion changes and documentation. Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua DeMott | Rush University Medical Center | 312-947-0226 | joshua_demott@rush.edu |
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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 | Sep 3, 2016 | Jun 28, 2022 | Prot_SAP_000.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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| 6, 12, 24, 48 hours |
| Hydrocortisone Use | Cumulative hydrocortisone (mg) use at different time points | 6, 12, 24, 48 hours |
| Cumulative Vasopressor Dose for Patients Receiving Other Antihypertensives | To determine cumulative vasopressor dose at various time points of patients on chronic calcium channel blocker or other antihypertensives (i.e., hydralazine, clonidine, angiotensin-receptor-blocker (ARB), etc). Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | 6, 12, 24, 48 hours |
| 6-hour Vasopressor Dose | Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | 6 hours |
| 12-hour Vasopressor Dose | Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | 12 hours |
| 24-hour Vasopressor Dose | Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | 24 hours |
| BG002 | ACE-Inhibitor | on chronic ACE-Inhibitor |
| BG003 | Both β-blocker and ACE-inhibitor | on both chronic β-blocker and ACE-inhibitor |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Beta-blocker only
| OG002 | Ace Inhibitor | Ace inhibitor |
| OG003 | Beta-blocker and ACE Inhibitor | Beta-blocker and ACE inhibitor |
|
|
| Secondary | 30 mL/kg Fluid Within 6h | Number of Participants with 30 mL/kg Fluid Within 6 Hours | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | Inotrope Use | Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone | Not Posted | 6, 12, 24, 48 hours | Participants |
| Secondary | Hydrocortisone Use | Cumulative hydrocortisone (mg) use at different time points | Not Posted | 6, 12, 24, 48 hours | Participants |
| Secondary | Cumulative Vasopressor Dose for Patients Receiving Other Antihypertensives | To determine cumulative vasopressor dose at various time points of patients on chronic calcium channel blocker or other antihypertensives (i.e., hydralazine, clonidine, angiotensin-receptor-blocker (ARB), etc). Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | Not Posted | 6, 12, 24, 48 hours | Participants |
| Secondary | 6-hour Vasopressor Dose | Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | Not Posted | 6 hours | Participants |
| Secondary | 12-hour Vasopressor Dose | Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | Not Posted | 12 hours | Participants |
| Secondary | 24-hour Vasopressor Dose | Vasopressor types and cumulative doses including: norepinephrine, epinephrine, phenylephrine, dopamine, and vasopressin. Epinephrine, phenylephrine, and dopamine will be converted to norepinephrine equivalents in concordance with other literature: 100 mcg dopamine equivalent to 1 mcg norepinephrine, 1 mcg epinephrine equivalent to 1 mcg norepinephrine, and 2.2 mcg phenylephrine equivalent to 1 mcg norepinephrine | Not Posted | 24 hours | Participants |
| 21 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | β-blocker | on chronic β-blocker | 26 | 46 | 0 | 46 | 0 | 46 |
| EG002 | ACE-Inhibitor | on chronic ACE-Inhibitor | 6 | 17 | 0 | 17 | 0 | 17 |
| EG003 | Both β-blocker and ACE-inhibitor | on both chronic β-blocker and ACE-inhibitor | 11 | 19 | 0 | 19 | 0 | 19 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |