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Active, Not Recruiting

NCT Number: NCT06217562

Vasopressin for Septic Shock Pragmatic Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cassia Regional Hospital, Burley, Idaho, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

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.

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)

Primary outcomes

  1. 28-day all-cause mortality

    Time frame: 28 days

    Death on or before study day 28

Secondary outcomes

  1. Renal replacement therapy-free days to day 28

    Time frame: 28 days

    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.

Other outcomes

  1. In-hospital all-cause mortality

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

    Death prior to discharge from the hospital

  2. 90-day all-cause mortality

    Time frame: 90 days

    Death on or before study day 90

  3. Vasopressor-free days to day 28

    Time frame: 28 days

    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.

  4. Incidence of new renal replacement therapy

    Time frame: From onset of septic shock until hospital discharge, an average of 10 days

    New receipt of renal replacement therapy after onset of septic shock. Patients receiving renal replacement therapy prior to enrollment are excluded from this outcome.

  5. Intensive care unit-free days to day 28

    Time frame: 28 days

    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.

  6. Hospital-free days to day 28

    Time frame: 28 days

    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.

  7. Incidence of acute coronary syndrome

    Time frame: From onset of septic shock until hospital discharge, an average of 10 days

    Documented new-onset clinical diagnosis of acute coronary syndrome or myocardial infarction

  8. Incidence of mesenteric ischemia

    Time frame: From onset of septic shock until hospital discharge, an average of 10 days

    Documented new-onset clinical diagnosis of mesenteric ischemia

  9. Incidence of soft tissue ischemia

    Time frame: From onset of septic shock until hospital discharge, an average of 10 days

    Documented new-onset clinical diagnosis of extremity, nose, or ear ischemia

  10. Incidence of vasopressor extravasation

    Time frame: From onset of septic shock until hospital discharge, an average of 10 days

    Documented clinical diagnosis of vasopressor extravasation

  11. Incidence of clinically-significant arrhythmia

    Time frame: From onset of septic shock until hospital discharge, an average of 10 days

    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)

  12. Incidence of cardiogenic shock

    Time frame: From onset of septic shock until hospital discharge, an average of 10 days

    Documented clinical diagnosis of cardiogenic shock

  13. Incidence of cardiac arrest

    Time frame: From onset of septic shock until hospital discharge, an average of 10 days

    Documented occurrence of a cardiac arrest with administration of chest compressions or defibrillation

  14. Incidence of severe hyponatremia

    Time frame: From onset of septic shock until hospital discharge, an average of 10 days

    New-onset severe hyponatremia (serum sodium <120 milliequivalents/liter)

  15. Maximum lactate

    Time frame: 7 days

    Maximum lactate value (millimoles/liter) from enrollment through study day 7

  16. Incidence of abnormal troponin

    Time frame: 7 days

    Serum troponin above the upper limit of normal for assay in interval from enrollment through study day 7

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • University of Utah

Registry information

Acronym: VASSPR

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 22, 2024
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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