Vasopressin for Septic Shock

(VASSPR Trial)

Recruiting at 13 trial locations

Overseen By Valerie Aston, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Intermountain Health Care, Inc.

Must be taking: Vasopressors

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

2050 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Vasopressin for treating septic shock?

Research shows that vasopressin can help stabilize blood pressure in patients with septic shock, which is a serious condition where blood pressure drops dangerously low. Studies suggest that vasopressin may be more effective than some other treatments, like catecholamines, in improving outcomes for these patients. ^{1 2 3 4 5}

Is vasopressin safe for use in humans?

Vasopressin is generally considered safe when used as a second-line treatment for septic shock, but higher doses may cause adverse effects like excessive blood vessel constriction. More large-scale studies are needed to fully understand its safety profile. ^{1 6 7 8 9}

How is the drug vasopressin unique in treating septic shock?

Vasopressin is unique in treating septic shock because it can restore blood vessel tone in patients with vasopressin deficiency, reducing the need for other drugs like catecholamines. It is used as a second-line treatment alongside norepinephrine to help maintain blood pressure. ^{7 9 10 11 12}

Research Team

Ithan Peltan, MD

Principal Investigator

Intermountain Health

Eligibility Criteria

Adults over 18 with life-threatening low blood pressure due to a serious infection (septic shock) and being treated in the emergency department or inpatient care unit of a study hospital. They must be receiving vasopressors for septic shock.

Inclusion Criteria

I am receiving medication to manage low blood pressure due to septic shock.

I am 18 years old or older.

Admitted to a study hospital emergency department (ED) or inpatient care unit

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive vasopressin as a second-line vasopressor based on different threshold strategies for septic shock treatment

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Extended Follow-up

Participants are monitored for long-term outcomes such as 90-day all-cause mortality

90 days

Treatment Details

Interventions

• Vasopressin

Trial Overview The trial is testing two strategies for when to add vasopressin, a second-line blood pressure-raising medication, to initial treatment. One group will receive vasopressin at a lower threshold, while another at a higher threshold, to see which approach is more effective.

Participant Groups

Group I: Septic shock treatment strategy involving a lower threshold for vasopressin initiation Active Control 2 Interventions

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.

Group II: Septic shock treatment strategy involving a higher threshold for vasopressin initiation Active Control 2 Interventions

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.

Vasopressin is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Vasostrict for:

• Central diabetes insipidus
• Postoperative abdominal distension
• Bleeding esophageal varices
• Abdominal roentgenography

Approved in Canada as Pitressin for:

• Central diabetes insipidus
• Postoperative abdominal distension
• Bleeding esophageal varices
• Abdominal roentgenography

Approved in European Union as Vasopressin for:

• Central diabetes insipidus
• Postoperative abdominal distension
• Bleeding esophageal varices
• Abdominal roentgenography

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of continuous vasopressin infusion in patients with septic shock. [2004]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Efficiency of Vasopressin or Its Analogs in Comparison With Catecholamines Alone on Patients With Septic Shock: A Systematic Review and Meta-Analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of early vasopressin use on patients with septic shock: A systematic review and meta-analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

The long-term survival rate of catecholamine-resistant septic shock in Japanese patients who received vasopressin therapy. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The Vasopressin Loading for Refractory septic shock (VALOR) study: a prospective observational study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Narrative Review of Controversies Involving Vasopressin Use in Septic Shock and Practical Considerations. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Physiology of vasopressin relevant to management of septic shock. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Vasopressin. [2005]

10. France pubmed.ncbi.nlm.nih.gov

[Indications of vasopressin in the management of septic shock]. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

The cardiopulmonary effects of vasopressin compared with norepinephrine in septic shock. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Beneficial effects of short-term vasopressin infusion during severe septic shock. [2022]