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Vasopressin for Septic Shock Pragmatic (VASSPR) 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.

Trial
Journal Ref. Peltan, Ithan D. et al. Protocol and Statistical Analysis Plan for the Vasopressin for Septic Shock Pragmatic (VASSPR) Cluster-Crossover Randomized Trial. CHEST Critical Care. [Epub ahead of print, available at: https://www.chestcc.org/article/S2949-7884(25)00051-6/fulltext]
Intervention Behavioural change (professionals) - (1) Lower-threshold strategy: 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). (2) 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. Study hospitals are randomly assigned to use one of two vasopressor management strategies for septic shock. After the initial study month, each hospital crosses over to the alternative strategy on a monthly basis through the end of the study. For individual patients, use of the assigned recommended treatment strategy or an alternative treatment strategy is at the discretion of patients' treating clinical team.
Number of sites 13
Countries involved United States of America
Sample size 2050
Type of statistical analyses
Participant characteristics Age: ≥18 years
Condition: Septic shock
Baseline severity:
Duration of trial 18 months
Primary outcome 28-day all-cause, all-location mortality
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
5 5 4 4 4 4 5 5 5

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