Current partner codePEPTIDESDE
NCT06217562·Phase 4·INTERVENTIONAL

Vasopressin for Septic Shock Pragmatic Trial

Status

Active, not recruiting

Phase

Phase 4

Enrollment

2,050

Locations

13

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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)

OTHER

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)

Timeline

From registration to results.

  1. First posted

    Jan 22, 2024

  2. Study start

    Feb 1, 2024

  3. Primary completion

    Jul 2026

  4. Study completion

    Dec 2027

  5. Results posted

    Not reported

  6. Registry updated

    Oct 21, 2025

Outcomes

What the study measures.

Primary outcomes

28-day all-cause mortality

Time frame · 28 days

Death on or before study day 28

Secondary outcomes

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

13 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Cassia Regional Hospital

Burley, Idaho, United States

American Fork Hospital

American Fork, Utah, 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

LDS Hospital

Salt Lake City, Utah, United States

Alta View Hospital

Sandy City, Utah, United States

St. George Regional Hospital

St. George, Utah, United States

Related trials

More studies on Vasopressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.