Septic Shock
Conditions
Keywords
Chronic antihypertensives, Septic shock, Vasopressor, Vasopressor dosing
Brief summary
Retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing in septic shock
Detailed description
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
Interventions
None listed
Sponsors
Rush University Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients 18 years of age or older * Diagnosis of septic shock requiring vasopressor therapy (norepinephrine, epinephrine, phenylephrine, dopamine, or vasopressin) * Admitted to an intensive care unit (ICU) at Rush University Medical Center (RUMC) * Time frame: 01/01/2012 to 07/1/2016
Exclusion criteria
* Pregnant patients * Transfer from outside hospital on vasopressors * Admitted in cardiopulmonary arrest * Prior arrest within 24 hours of admission to RUMC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Vasopressor Dose | 48 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inotrope Use | 6, 12, 24, 48 hours | Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone |
| Hydrocortisone Use | 6, 12, 24, 48 hours | Cumulative hydrocortisone (mg) use at different time points |
| Cumulative Vasopressor Dose for Patients Receiving Other Antihypertensives | 6, 12, 24, 48 hours | 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 |
| 30 mL/kg Fluid Within 6h | 48 hours | Number of Participants with 30 mL/kg Fluid Within 6 Hours |
| 12-hour Vasopressor Dose | 12 hours | 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-hour Vasopressor Dose | 24 hours | 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-hour Vasopressor Dose | 6 hours | 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 |
Countries
United States
Participant flow
Pre-assignment details
retrospective study
Participants by arm
| Arm | Count |
|---|---|
| No Chronic Antihypertensives not on either a chronic β-blocker or ACE-Inhibitor | 51 |
| β-blocker on chronic β-blocker | 46 |
| ACE-Inhibitor on chronic ACE-Inhibitor | 17 |
| Both β-blocker and ACE-inhibitor on both chronic β-blocker and ACE-inhibitor | 19 |
| Total | 133 |
Baseline characteristics
| Characteristic | No Chronic Antihypertensives | Total | Both β-blocker and ACE-inhibitor | ACE-Inhibitor | β-blocker |
|---|---|---|---|---|---|
| Age, Continuous | 62 years | 65 years | 66 years | 70 years | 67 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 60 Participants | 9 Participants | 6 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 20 Participants | 3 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 23 Participants | 53 Participants | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Female | 19 Participants | 59 Participants | 11 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 32 Participants | 74 Participants | 8 Participants | 10 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 21 / 51 | 26 / 46 | 6 / 17 | 11 / 19 |
| other Total, other adverse events | 0 / 51 | 0 / 46 | 0 / 17 | 0 / 19 |
| serious Total, serious adverse events | 0 / 51 | 0 / 46 | 0 / 17 | 0 / 19 |
Outcome results
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
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Beta-blocker or ACE Inhibitor | Total Vasopressor Dose | 13.7 mg |
| Beta-blocker Only | Total Vasopressor Dose | 13.1 mg |
| Ace Inhibitor | Total Vasopressor Dose | 13.2 mg |
| Beta-blocker and ACE Inhibitor | Total Vasopressor Dose | 11.3 mg |
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
Time frame: 12 hours
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
Time frame: 24 hours
Secondary
30 mL/kg Fluid Within 6h
Number of Participants with 30 mL/kg Fluid Within 6 Hours
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Beta-blocker or ACE Inhibitor | 30 mL/kg Fluid Within 6h | 36 Participants |
| Beta-blocker Only | 30 mL/kg Fluid Within 6h | 27 Participants |
| Ace Inhibitor | 30 mL/kg Fluid Within 6h | 12 Participants |
| Beta-blocker and ACE Inhibitor | 30 mL/kg Fluid Within 6h | 16 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
Time frame: 6 hours
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
Time frame: 6, 12, 24, 48 hours
Secondary
Hydrocortisone Use
Cumulative hydrocortisone (mg) use at different time points
Time frame: 6, 12, 24, 48 hours
Secondary
Inotrope Use
Cumulative inotrope use at different time points (total mg). Example inotropes include dobutamine and milrinone
Time frame: 6, 12, 24, 48 hours