Vasopressin for Septic Shock Pragmatic Trial (VASSPR)

Intermountain Health Care, Inc.

Status and phase: Invitation-only; Phase 4

Conditions: Septic Shock

Treatments: Other: Recommendation to use a higher initiation threshold for vasopressin; Other: Recommendation to use a lower initiation threshold for vasopressin; Drug: Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT06217562

1052518

Details and patient eligibility

About

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.

Enrollment: 2,050 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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2,050 participants in 2 patient groups

Septic shock treatment strategy involving a lower threshold for vasopressin initiation

Active Comparator group

Description:

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.

Treatment:

Drug: Vasopressin

Other: Recommendation to use a lower initiation threshold for vasopressin

Septic shock treatment strategy involving a higher threshold for vasopressin initiation

Active Comparator group

Description:

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.

Treatment:

Drug: Vasopressin

Other: Recommendation to use a higher initiation threshold for vasopressin