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Vasopressor

Vasopressin for Septic Shock (VASSPR Trial)

Phase 4

Waitlist Available

Led By Ithan Peltan, MD, MSc

Research Sponsored by Intermountain Health Care, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Administration of vasopressor(s) for septic shock

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is looking at different strategies for treating a serious infection called septic shock. One of the treatments is a medication called vasopressin, which helps raise blood pressure. The trial will compare

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Vasopressin can cause side effects like abnormal heart rhythms, decreased cardiac output, changes in skin color due to reduced blood flow, and water retention leading to an imbalance of sodium levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

28-day all-cause mortality

Secondary study objectives

Renal replacement therapy-free days to day 28

Other study objectives

90-day all-cause mortality

Hospital-free days to day 28

In-hospital all-cause mortality

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: Septic shock treatment strategy involving a lower threshold for vasopressin initiationActive Control2 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 initiationActive Control2 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.

0 / 2Eligibility criteria met