Septic Shock
Conditions
Keywords
Vasopressin, Vasopressors, Treatment strategy
Brief summary
Life-threatening low blood pressure due to a serious infection is called "septic shock." Septic shock is treated with vasopressors, medications that raise blood pressure. Sometimes first-line vasopressors are inadequate, prompting addition of a second-line vasopressor called vasopressin. However, the threshold at which to start vasopressin remains unclear. This pragmatic, cluster-randomized, cluster-crossover trial will evaluate two different strategies for septic shock treatment commonly used in current practice, comparing a lower versus a higher threshold for adding vasopressin to first-line vasopressors.
Interventions
OTHERRecommendation to use a higher initiation threshold for vasopressin
Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.4 mcg/kg/min of norepinephrine (or equivalent)
DRUGVasopressin
Intravenous vasopressin infusion added to first-line vasopressors. Recommended vasopressin dose is 1.8 units/hour (equivalent to 0.03 units/minute) at a fixed rate.
OTHERRecommendation to use a lower initiation threshold for vasopressin
Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.1 mcg/kg/min of norepinephrine (or equivalent)
Sponsors
Intermountain Health Care, Inc.
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Pragmatic embedded cluster-randomized cluster-crossover comparative effectiveness trial. Study hospitals will be assigned to a vasopressin-initiation strategy (cluster randomized) and the hospital will then alternate monthly between the tested vasopressin-initiation strategies in a randomized sequence (cluster-crossover).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Admitted to a study hospital emergency department (ED) or inpatient care unit 3. Administration of vasopressor(s) for septic shock
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day all-cause mortality | 28 days | Death on or before study day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal replacement therapy-free days to day 28 | 28 days | Number of days between day 28 and the end of the last period of renal replacement therapy prior to day 28. Death on or before day 28 will be assigned a value of -1. For patients with baseline end-stage renal failure on dialysis prior to the index hospitalization, potential values for this ordinal outcome will be 0 or -1. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIthan Peltan, MD, MSc
Intermountain Health
Outcome results
None listed