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| Name | Class |
|---|---|
| University of Utah | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septic shock treatment strategy involving a lower threshold for vasopressin initiation | Active Comparator | 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. |
|
| Septic shock treatment strategy involving a higher threshold for vasopressin initiation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality | Death on or before study day 28 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 90-day all-cause mortality | Death on or before study day 90 |
Inclusion Criteria:
Exclusion Criteria: None
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| Name | Affiliation | Role |
|---|---|---|
| Ithan Peltan, MD, MSc | Intermountain Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cassia Regional Hospital | Burley | Idaho | 83318 | United States | ||
| American Fork Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41552411 | Derived | Peltan ID, Groat D, Jacobs JR, Tillman EH, Brintz BJ, Chauv S, Beesley SJ, Edwards JH, Arizmendez N, Hirshberg EL, Carr JR, Lanspa MJ, Bledsoe JR, Smith AT, Schneider H, Hu P, Moores Todd TD, Klippel C, Semler MW, Casey JW, Grissom CK, Brown SM, Leither LM. Protocol and Statistical Analysis Plan for the Vasopressin for Septic Shock Pragmatic (VASSPR) Cluster-Crossover Randomized Trial. CHEST Crit Care. 2025 Dec;3(4):100178. doi: 10.1016/j.chstcc.2025.100178. Epub 2025 Nov 12. |
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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.
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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).
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| Recommendation to use a lower initiation threshold for vasopressin | Other | 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 | Other | Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.4 mcg/kg/min of norepinephrine (or equivalent) |
|
| 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. | 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. | 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. | 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. | 28 days |
| 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 |
| 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 |
| 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 |
| Incidence of vasopressor extravasation | Documented clinical diagnosis of vasopressor extravasation | 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) | From onset of septic shock until hospital discharge, an average of 10 days |
| Incidence of cardiogenic shock | Documented clinical diagnosis of cardiogenic shock | 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 | 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) | 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 | 7 days |
| Incidence of abnormal troponin | Serum troponin above the upper limit of normal for assay in interval from enrollment through study day 7 | 7 days |
| American Fork |
| Utah |
| 84003 |
| United States |
| Cedar City Hospital | Cedar City | Utah | 84721 | United States |
| Layton Hospital | Layton | Utah | 84041 | United States |
| Logan Regional Hospital | Logan | Utah | 84341 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital | Ogden | Utah | 84403 | United States |
| Park City Hospital | Park City | Utah | 84060 | United States |
| Utah Valley Hospital | Provo | Utah | 84604 | United States |
| Riverton Hospital | Riverton | Utah | 84065 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Alta View Hospital | Sandy City | Utah | 84094 | United States |
| St. George Regional Hospital | St. George | Utah | 84790 | United States |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014667 | Vasopressins |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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