Vasopressin for Septic Shock
(VASSPR Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen byIthan Peltan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Intermountain Health Care, Inc.

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with life-threatening low blood pressure due to a serious infection (septic shock) and being treated in the emergency department or inpatient care unit of a study hospital. They must be receiving vasopressors for septic shock.

Inclusion Criteria

I am receiving medication to manage low blood pressure due to septic shock.

I am 18 years old or older.

Admitted to a study hospital emergency department (ED) or inpatient care unit

Exclusion Criteria

N/A

Participant Groups

The trial is testing two strategies for when to add vasopressin, a second-line blood pressure-raising medication, to initial treatment. One group will receive vasopressin at a lower threshold, while another at a higher threshold, to see which approach is more effective.

2Treatment groups

Active Control

Group I: Septic shock treatment strategy involving a lower threshold for vasopressin initiationActive Control2 Interventions

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.

Group II: Septic shock treatment strategy involving a higher threshold for vasopressin initiationActive Control2 Interventions

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.

Vasopressin is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Vasostrict for: