Vasopressin for Septic Shock Pragmatic Trial

Phase 4Active Not RecruitingNCT06217562

Intermountain Health Care, Inc.2,050 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

2,050

Conditions

Septic Shock

Interventions

VasopressinDRUG

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.

Recommendation to use a lower initiation threshold for vasopressinOTHER

Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.1 mcg/kg/min of norepinephrine (or equivalent)

Recommendation to use a higher initiation threshold for vasopressinOTHER

Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.4 mcg/kg/min of norepinephrine (or equivalent)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Cassia Regional Hospital

Burley, Idaho, United States

American Fork Hospital

American Fork, Utah, United States

Cedar City Hospital

Cedar City, Utah, United States

Outcomes

Primary Outcomes

28-day all-cause mortality

Death on or before study day 28

Time frame: 28 days

Secondary Outcomes

Renal replacement therapy-free days to day 28

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.

Time frame: 28 days

Data from ClinicalTrials.gov

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