Septic ShockPhase 4VASSPRNCT06217562
Vasopressin for Septic Shock Pragmatic Trial
A Phase 4 study testing Vasopressin, Recommendation to use a lower initiation threshold for vasopressin and Recommendation to use a higher initiation threshold for vasopressin in people with Septic Shock, run by Intermountain Health Care, Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Vasopressin, Recommendation to use a lower initiation threshold for vasopressin and Recommendation to use a higher initiation threshold for vasopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,959 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Feb 2024to 6 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Admitted to a study hospital emergency department (ED) or inpatient care unit
- Administration of vasopressor(s) for septic shock
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
American Fork Hospital
American Fork, Utah, 84003
Cassia Regional Hospital
Burley, Idaho, 83318
Cedar City Hospital
Cedar City, Utah, 84721
Layton Hospital
Layton, Utah, 84041
Logan Regional Hospital
Logan, Utah, 84341
Intermountain Medical Center
Murray, Utah, 84107
McKay-Dee Hospital
Ogden, Utah, 84403
Park City Hospital
Park City, Utah, 84060
Utah Valley Hospital
Provo, Utah, 84604
Riverton Hospital
Riverton, Utah, 84065
LDS Hospital
Salt Lake City, Utah, 84143
Alta View Hospital
Sandy City, Utah, 84094
St. George Regional Hospital
St. George, Utah, 84790
About this study
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
- Being tested
- Vasopressin, Recommendation to use a lower initiation threshold for vasopressin, Recommendation to use a higher initiation threshold for vasopressin
- Keywords
- Vasopressin, Vasopressors, Treatment strategy
- Medical subject headings
- Shock, Septic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
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 vasopressinOther
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 vasopressinOther
Recommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.4 mcg/kg/min of norepinephrine (or equivalent)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vasopressin; Other: Recommendation to use a higher initiation threshold for vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
Death on or before study day 28
Measured: 28 days
Secondary outcomes (1)
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Feb 2024
- Primary completion17 Feb 2026
- Study completion6 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,959 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Ithan Peltan, MD, MSc, Principal investigator, Intermountain Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217562
- Sponsor's protocol ID
- 1052518
- Acronym
- VASSPR
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 41552411Peltan ID, Groat D, Jacobs JR, Tillman EH, Klippel C, Brintz BJ, Chauv S, Arizmendez N, Beesley SJ, Carr JR, Edwards JH, Hirshberg EL, Lanspa MJ, Schneider H, Hu P, Moores Todd TD, Bledsoe JR, Smith AT, Semler MW, Casey JD, Grissom CK, Brown SM, Leither LM. Effect of Vasopressin Initiation Threshold on Septic Shock Mortality: The VASSPR Cluster Crossover Randomized Strategy Trial. JAMA. 2026 Oct 14. doi: 10.1001/jama.2026.21333. Online ahead of print.
PubMed 42872917
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin for Septic Shock Pragmatic Trial
- ClinicalTrials.gov ID
- NCT06217562
- Acronym / sponsor ID
- VASSPR / 1052518
- Conditions
- Septic Shock
- Keywords
- Vasopressin, Vasopressors, Treatment strategy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,959 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- University of Utah
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 6 Jun 2026 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Septic shock treatment strategy involving a lower threshold for vasopressin initiation | Active comparator | Drug: Vasopressin, Other: Recommendation to use a lower initiation threshold for vasopressinRecommended 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 | Drug: Vasopressin, Other: Recommendation to use a higher initiation threshold for vasopressinRecommended 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Admitted to a study hospital emergency department (ED) or inpatient care unit
- Administration of vasopressor(s) for septic shock
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasopressinIntravenous 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. | Drug | 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 vasopressinRecommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.1 mcg/kg/min of norepinephrine (or equivalent) | Other | Septic shock treatment strategy involving a lower threshold for vasopressin initiation |
| Recommendation to use a higher initiation threshold for vasopressinRecommended to initiate intravenous vasopressin infusion if the combined dose of other vasopressors reaches ≥0.4 mcg/kg/min of norepinephrine (or equivalent) | Other | Septic shock treatment strategy involving a higher threshold for vasopressin initiation |
Primary outcome
28-day all-cause mortality
Time frame: 28 days
Death on or before study day 28
1 secondary outcome
Renal replacement therapy-free days to day 28
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 41552411Peltan 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.
- Derived from this study: PubMed 42872917Peltan ID, Groat D, Jacobs JR, Tillman EH, Klippel C, Brintz BJ, Chauv S, Arizmendez N, Beesley SJ, Carr JR, Edwards JH, Hirshberg EL, Lanspa MJ, Schneider H, Hu P, Moores Todd TD, Bledsoe JR, Smith AT, Semler MW, Casey JD, Grissom CK, Brown SM, Leither LM. Effect of Vasopressin Initiation Threshold on Septic Shock Mortality: The VASSPR Cluster Crossover Randomized Strategy Trial. JAMA. 2026 Oct 14. doi: 10.1001/jama.2026.21333. Online ahead of print.
- Individual participant dataSharing planned: 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.
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Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ithan Peltan, MD, MSc principal investigator
Intermountain Health
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vasopressin, Recommendation to use a lower initiation threshold for vasopressin and Recommendation to use a higher initiation threshold for vasopressin in people with Septic Shock, run by Intermountain Health Care, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217562, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.