Vasopressin for Septic Shock Pragmatic Trial
Overview
- Phase
- Phase 4
- Intervention
- Vasopressin
- Conditions
- Septic Shock
- Sponsor
- Intermountain Health Care, Inc.
- Enrollment
- 2050
- Locations
- 13
- Primary Endpoint
- 28-day all-cause mortality
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years
- •Admitted to a study hospital emergency department (ED) or inpatient care unit
- •Administration of vasopressor(s) for septic shock
Exclusion Criteria
- Not provided
Arms & Interventions
Septic shock treatment strategy involving a lower threshold for vasopressin initiation
Recommended strategy for treatment of septic shock includes initiation of fixed-dose IV vasopressin (1.8 units/hour) as a second-line vasopressor if the combined norepinephrine-equivalent dose of other vasopressors reaches ≥0.1 micrograms/kilogram/minute (mcg/kg/min). Use of the recommended treatment strategy (via entry of an order for threshold-based vasopressin initiation) or an alternative treatment strategy is at the discretion of patients' treating clinical team.
Intervention: Vasopressin
Septic shock treatment strategy involving a lower threshold for vasopressin initiation
Recommended strategy for treatment of septic shock includes initiation of fixed-dose IV vasopressin (1.8 units/hour) as a second-line vasopressor if the combined norepinephrine-equivalent dose of other vasopressors reaches ≥0.1 micrograms/kilogram/minute (mcg/kg/min). Use of the recommended treatment strategy (via entry of an order for threshold-based vasopressin initiation) or an alternative treatment strategy is at the discretion of patients' treating clinical team.
Intervention: Recommendation to use a lower initiation threshold for vasopressin
Septic shock treatment strategy involving a higher threshold for vasopressin initiation
Recommended strategy for treatment of septic shock includes initiation of fixed-dose IV vasopressin (1.8 units/hour) as a second-line vasopressor if the combined norepinephrine-equivalent dose of other vasopressors reaches ≥0.4 mcg/kg/min. Use of the recommended treatment strategy (via entry of an order for threshold-based vasopressin initiation) or an alternative treatment strategy is at the discretion of patients' treating clinical team.
Intervention: Vasopressin
Septic shock treatment strategy involving a higher threshold for vasopressin initiation
Recommended strategy for treatment of septic shock includes initiation of fixed-dose IV vasopressin (1.8 units/hour) as a second-line vasopressor if the combined norepinephrine-equivalent dose of other vasopressors reaches ≥0.4 mcg/kg/min. Use of the recommended treatment strategy (via entry of an order for threshold-based vasopressin initiation) or an alternative treatment strategy is at the discretion of patients' treating clinical team.
Intervention: Recommendation to use a higher initiation threshold for vasopressin
Outcomes
Primary Outcomes
28-day all-cause mortality
Time Frame: 28 days
Death on or before study day 28
Secondary Outcomes
- Renal replacement therapy-free days to day 28(28 days)