A Phase 4 interventional study of Vasopressin and Recommendation to use a lower initiation threshold for vasopressin in Septic Shock, sponsored by Intermountain Health Care, Inc.. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Intermountain Health Care, Inc. · Phase 4, Interventional, and Treatment
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.
861 studies on the registry are indexed under Shock, Septic; 206 are open to participants now.
This study's enrollment of 3,959 is above the median of 79 across 529 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
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Inclusion Criteria:
Exclusion Criteria: None
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.
Drug: Vasopressin · Other: 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 ≥0.4 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.
Drug: Vasopressin · Other: Recommendation to use a higher initiation threshold for 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.
Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.1 mcg/kg/min of norepinephrine (or equivalent)
Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.4 mcg/kg/min of norepinephrine (or equivalent)
28-day all-cause mortality
Death on or before study day 28
Time frame: 28 days
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
In-hospital all-cause mortality
Death prior to discharge from the hospital
Time frame: From onset of septic shock to hospital discharge, an average of 10 days
90-day all-cause mortality
Death on or before study day 90
Time frame: 90 days
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.
Time frame: 28 days
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.
Time frame: From onset of septic shock until hospital discharge, an average of 10 days
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.
Time frame: 28 days
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.
Time frame: 28 days
Incidence of acute coronary syndrome
Documented new-onset clinical diagnosis of acute coronary syndrome or myocardial infarction
Time frame: From onset of septic shock until hospital discharge, an average of 10 days
Incidence of mesenteric ischemia
Documented new-onset clinical diagnosis of mesenteric ischemia
Time frame: From onset of septic shock until hospital discharge, an average of 10 days
Incidence of soft tissue ischemia
Documented new-onset clinical diagnosis of extremity, nose, or ear ischemia
Time frame: From onset of septic shock until hospital discharge, an average of 10 days
Incidence of vasopressor extravasation
Documented clinical diagnosis of vasopressor extravasation
Time frame: From onset of septic shock until hospital discharge, an average of 10 days
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)
Time frame: From onset of septic shock until hospital discharge, an average of 10 days
Incidence of cardiogenic shock
Documented clinical diagnosis of cardiogenic shock
Time frame: From onset of septic shock until hospital discharge, an average of 10 days
Incidence of cardiac arrest
Documented occurrence of a cardiac arrest with administration of chest compressions or defibrillation
Time frame: From onset of septic shock until hospital discharge, an average of 10 days
Incidence of severe hyponatremia
New-onset severe hyponatremia (serum sodium \<120 milliequivalents/liter)
Time frame: From onset of septic shock until hospital discharge, an average of 10 days
Maximum lactate
Maximum lactate value (millimoles/liter) from enrollment through study day 7
Time frame: 7 days
Incidence of abnormal troponin
Serum troponin above the upper limit of normal for assay in interval from enrollment through study day 7
Time frame: 7 days
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
Supporting information: Study protocol, Sap
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Intermountain Health Care, Inc.