DRUG
Vasopressin
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.
Status
Active, not recruiting
Phase
Phase 4
Enrollment
2,050
Locations
13
Results
Not posted
Publications
1
Study 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
DRUG
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.
OTHER
Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.1 mcg/kg/min of norepinephrine (or equivalent)
OTHER
Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.4 mcg/kg/min of norepinephrine (or equivalent)
Timeline
First posted
Jan 22, 2024
Study start
Feb 1, 2024
Primary completion
Jul 2026
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Oct 21, 2025
Outcomes
28-day all-cause mortality
Time frame · 28 days
Death on or before study day 28
Renal replacement therapy-free days to day 28
Time frame · 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.
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Cassia Regional Hospital
Burley, Idaho, United States
American Fork Hospital
American Fork, Utah, United States
Cedar City Hospital
Cedar City, Utah, United States
Layton Hospital
Layton, Utah, United States
Logan Regional Hospital
Logan, Utah, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital
Ogden, Utah, United States
Park City Hospital
Park City, Utah, United States
Utah Valley Hospital
Provo, Utah, United States
Riverton Hospital
Riverton, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Alta View Hospital
Sandy City, Utah, United States
St. George Regional Hospital
St. George, Utah, United States
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