Vasopressin for Septic Shock Pragmatic Trial

NCT06217562 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 1052518
• Study Type: interventional
• Target: 2,050
• Locations: 1 country
• Sites: 13

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.

Conditions

Septic Shock

Keywords

Vasopressin; Vasopressors; Treatment strategy

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

  Death on or before study day 28

  28 days

Secondary Outcomes (1)

• Renal replacement therapy-free days to day 28

  28 days

Other Outcomes (16)

• In-hospital all-cause mortality

  From onset of septic shock to hospital discharge, an average of 10 days

• 90-day all-cause mortality

  90 days

• Vasopressor-free days to day 28

  28 days

Study Arms (2)

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.

Drug: Vasopressin; Other: Recommendation to use a lower initiation threshold for vasopressin

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.

Drug: Vasopressin; Other: Recommendation to use a higher initiation threshold for vasopressin

Interventions

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.

Septic shock treatment strategy involving a higher threshold for vasopressin initiation; Septic shock treatment strategy involving a lower threshold for vasopressin initiation

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)

Septic shock treatment strategy involving a lower threshold for vasopressin initiation

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)

Septic shock treatment strategy involving a higher threshold for vasopressin initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Admitted to a study hospital emergency department (ED) or inpatient care unit
• Administration of vasopressor(s) for septic shock

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• University of Utah: collaborator

Study Sites (13)

Cassia Regional Hospital

Burley, Idaho, 83318, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Cedar City Hospital

Cedar City, Utah, 84721, United States

Location

Layton Hospital

Layton, Utah, 84041, United States

Location

Logan Regional Hospital

Logan, Utah, 84341, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Park City Hospital

Park City, Utah, 84060, United States

Location

Utah Valley Hospital

Provo, Utah, 84604, United States

Location

Riverton Hospital

Riverton, Utah, 84065, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Alta View Hospital

Sandy City, Utah, 84094, United States

Location

St. George Regional Hospital

St. George, Utah, 84790, United States

Location

Related Publications (1)

• 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.

  PMID: 41552411 DERIVED

MeSH Terms

Conditions

Shock, Septic; Diabetes Insipidus

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Ithan Peltan, MD, MSc

  Intermountain Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 22, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (13)