Vasopressin for Septic Shock Pragmatic Trial

Septic Shock Clinical Trial

— VASSPR  

Official title:

Vasopressin for Septic Shock Pragmatic Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06217562
• Other study ID #: 1052518
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2050
• Est. completion date: December 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	American Fork Hospital	American Fork	Utah
United States	Cassia Regional Hospital	Burley	Idaho
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	St. George Regional Hospital	Saint George	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Alta View Hospital	Sandy	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	In-hospital all-cause mortality	Death prior to discharge from the hospital	From onset of septic shock to hospital discharge, an average of 10 days
Other	90-day all-cause mortality	Death on or before study day 90	90 days
Other	Vasopressor-free days to day 28	Number of days between day 28 and the end of the last period of vasopressor therapy prior to day 28. Death on or before day 28 will be assigned a value of -1.	28 days
Other	Incidence of new renal replacement therapy	New receipt of renal replacement therapy after onset of septic shock. Patients receiving renal replacement therapy prior to enrollment are excluded from this outcome.	From onset of septic shock until hospital discharge, an average of 10 days
Other	Intensive care unit-free days to day 28	Number of days between day 28 and the end of the last period of intensive care unit admission prior to day 28. Death on or before day 28 will be assigned a value of -1.	28 days
Other	Hospital-free days to day 28	Number of days between day 28 and the end of the last period of hospital admission prior to day 28. Death on or before day 28 will be assigned a value of -1.	28 days
Other	Incidence of acute coronary syndrome	Documented new-onset clinical diagnosis of acute coronary syndrome or myocardial infarction	From onset of septic shock until hospital discharge, an average of 10 days
Other	Incidence of mesenteric ischemia	Documented new-onset clinical diagnosis of mesenteric ischemia	From onset of septic shock until hospital discharge, an average of 10 days
Other	Incidence of soft tissue ischemia	Documented new-onset clinical diagnosis of extremity, nose, or ear ischemia	From onset of septic shock until hospital discharge, an average of 10 days
Other	Incidence of vasopressor extravasation	Documented clinical diagnosis of vasopressor extravasation	From onset of septic shock until hospital discharge, an average of 10 days
Other	Incidence of clinically-significant arrhythmia	Documented clinical diagnosis of clinically-significant arrhythmia (sustained ventricular tachycardia, reentrant [supraventricular] tachycardia, atrial arrhythmia with rapid ventricular response requiring intervention, or new-onset atrial fibrillation or flutter)	From onset of septic shock until hospital discharge, an average of 10 days
Other	Incidence of cardiogenic shock	Documented clinical diagnosis of cardiogenic shock	From onset of septic shock until hospital discharge, an average of 10 days
Other	Incidence of cardiac arrest	Documented occurrence of a cardiac arrest with administration of chest compressions or defibrillation	From onset of septic shock until hospital discharge, an average of 10 days
Other	Incidence of severe hyponatremia	New-onset severe hyponatremia (serum sodium <120 milliequivalents/liter)	From onset of septic shock until hospital discharge, an average of 10 days
Other	Maximum lactate	Maximum lactate value (millimoles/liter) from enrollment through study day 7	7 days
Other	Incidence of abnormal troponin	Serum troponin above the upper limit of normal for assay in interval from enrollment through study day 7	7 days
Primary	28-day all-cause mortality	Death on or before study day 28	28 days
Secondary	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.	28 days