Vasopressin for Septic Shock Pragmatic Trial

Phase 4

• Conditions: Septic Shock
• Interventions: Drug: Vasopressin; Other: Recommendation to use a lower initiation threshold for vasopressin; Other: Recommendation to use a higher initiation threshold for vasopressin

• Registration Number: NCT06217562
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-22
• Study Start: 2024-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-07
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2050

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Septic shock treatment strategy involving a lower threshold for vasopressin initiation	Recommendation to use a lower initiation threshold for vasopressin	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.
Septic shock treatment strategy involving a higher threshold for vasopressin initiation	Recommendation to use a higher initiation threshold for vasopressin	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.
Septic shock treatment strategy involving a lower threshold for vasopressin initiation	Vasopressin	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.
Septic shock treatment strategy involving a higher threshold for vasopressin initiation	Vasopressin	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.

Primary Outcome Measures

Name	Time	Method
28-day all-cause mortality	28 days	Death on or before study day 28

Secondary Outcome Measures

Name	Time	Method
Renal replacement therapy-free days to day 28	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.

Trial Locations

Locations (13)

Cedar City Hospital; 🇺🇸 Cedar City, Utah, United States

Layton Hospital; 🇺🇸 Layton, Utah, United States

Cassia Regional Hospital; 🇺🇸 Burley, Idaho, United States

American Fork Hospital; 🇺🇸 American Fork, 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, Utah, United States

St. George Regional Hospital; 🇺🇸 St. George, Utah, United States