Clinical trial NCT06217562: Vasopressin for Septic Shock Pragmatic Trial
Official title: Vasopressin for Septic Shock Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Septic Shock
Keywords: Vasopressin
Vasopressors
Treatment strategy
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2024-01-22
Enrollment: 2050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pragmatic embedded cluster-randomized cluster-crossover comparative effectiveness trial. Study hospitals will be assigned to a vasopressin-initiation strategy (cluster randomized) and the hospital will then alternate monthly between the tested vasopressin-initiation strategies in a randomized sequence (cluster-crossover).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 28-day all-cause mortality
timeFrame: 28 days
Secondary outcomes:
measure: Renal replacement therapy-free days to day 28
timeFrame: 28 days
Other outcomes:
measure: In-hospital all-cause mortality
timeFrame: From onset of septic shock to hospital discharge, an average of 10 days
measure: 90-day all-cause mortality
timeFrame: 90 days
measure: Vasopressor-free days to day 28
timeFrame: 28 days
measure: Incidence of new renal replacement therapy
timeFrame: From onset of septic shock until hospital discharge, an average of 10 days
measure: Intensive care unit-free days to day 28
timeFrame: 28 days
measure: Hospital-free days to day 28
timeFrame: 28 days
measure: Incidence of acute coronary syndrome
timeFrame: From onset of septic shock until hospital discharge, an average of 10 days
measure: Incidence of mesenteric ischemia
timeFrame: From onset of septic shock until hospital discharge, an average of 10 days
measure: Incidence of soft tissue ischemia
timeFrame: From onset of septic shock until hospital discharge, an average of 10 days
measure: Incidence of vasopressor extravasation
timeFrame: From onset of septic shock until hospital discharge, an average of 10 days
measure: Incidence of clinically-significant arrhythmia
timeFrame: From onset of septic shock until hospital discharge, an average of 10 days
measure: Incidence of cardiogenic shock
timeFrame: From onset of septic shock until hospital discharge, an average of 10 days
measure: Incidence of cardiac arrest
timeFrame: From onset of septic shock until hospital discharge, an average of 10 days
measure: Incidence of severe hyponatremia
timeFrame: From onset of septic shock until hospital discharge, an average of 10 days
measure: Maximum lactate
timeFrame: 7 days
measure: Incidence of abnormal troponin
timeFrame: 7 days
Locations:
city: Burley
country: United States
facility: Cassia Regional Hospital
state: Idaho
city: American Fork
country: United States
facility: American Fork Hospital
state: Utah
city: Cedar City
country: United States
facility: Cedar City Hospital
state: Utah
city: Layton
country: United States
facility: Layton Hospital
state: Utah
city: Logan
country: United States
facility: Logan Regional Hospital
state: Utah
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Park City
country: United States
facility: Park City Hospital
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Riverton
country: United States
facility: Riverton Hospital
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Sandy
country: United States
facility: Alta View Hospital
state: Utah
city: St. George
country: United States
facility: St. George Regional Hospital
state: Utah
Study officials:
affiliation: Intermountain Health
name: Ithan Peltan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: