NCT06217562

Vasopressin for Septic Shock Pragmatic Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,050 (estimated)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
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.
OTHER	Recommendation to use a lower initiation threshold for vasopressin	Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.1 mcg/kg/min of norepinephrine (or equivalent)
OTHER	Recommendation to use a higher initiation threshold for vasopressin	Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.4 mcg/kg/min of norepinephrine (or equivalent)

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-07-01
• Completion: 2027-12-01
• First posted: 2024-01-22
• Last updated: 2025-10-21

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study