Vasopressin for Septic Shock
(VASSPR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the optimal use of vasopressin, a medication that raises blood pressure, in treating septic shock—a serious condition where blood pressure drops dangerously low due to infection. The study compares two strategies: one initiates vasopressin at a lower threshold, and the other at a higher threshold when initial treatments prove insufficient. Suitable candidates for this trial are those already receiving treatment for septic shock in a hospital setting. The goal is to determine which approach more effectively stabilizes blood pressure. As a Phase 4 trial, this research aims to understand how an FDA-approved and effective treatment can benefit more patients.
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 is the safety track record for vasopressin?
Research has shown that vasopressin is generally safe for patients with septic shock. Studies have found that using vasopressin with norepinephrine (a common treatment) can shorten hospital stays by about 4.5 days, aiding recovery. One study found that low-dose vasopressin did not increase death rates compared to norepinephrine, indicating it is not riskier than the usual treatment.
However, vasopressin did not significantly improve kidney issues or reduce the need for dialysis, which cleans the blood when kidneys aren't functioning well. Overall, the safety data suggests that vasopressin is a reliable option for managing blood pressure in septic shock cases.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about this trial because it explores different strategies for initiating vasopressin in treating septic shock, a condition typically managed with vasopressors like norepinephrine. The trial compares two strategies: one involves starting vasopressin at a lower threshold of norepinephrine-equivalent doses (≥0.1 mcg/kg/min), while the other uses a higher threshold (≥0.4 mcg/kg/min). By evaluating these thresholds, researchers aim to optimize vasopressin use, potentially improving patient outcomes and offering more personalized treatment strategies for septic shock.
What evidence suggests that this trial's treatments could be effective for septic shock?
Research has shown that using vasopressin early in septic shock can benefit patients. Studies indicate that early administration can reduce hospital stays by about 4.5 days. However, it does not appear to affect ICU duration or the SOFA score, which measures organ health. Clinicians typically add vasopressin when first-choice drugs fail to sufficiently raise blood pressure. Although it does not lower death rates more than norepinephrine, it remains a common choice for additional support. This trial explores the optimal timing for vasopressin initiation, with one arm testing a lower threshold and another arm testing a higher threshold.13467
Who Is on the Research Team?
Ithan Peltan, MD
Principal Investigator
Intermountain Health
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vasopressin as a second-line vasopressor based on different threshold strategies for septic shock treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
Participants are monitored for long-term outcomes such as 90-day all-cause mortality
What Are the Treatments Tested in This Trial?
Interventions
- Vasopressin
Vasopressin is already approved in United States, Canada, European Union for the following indications:
- Central diabetes insipidus
- Postoperative abdominal distension
- Bleeding esophageal varices
- Abdominal roentgenography
- Central diabetes insipidus
- Postoperative abdominal distension
- Bleeding esophageal varices
- Abdominal roentgenography
- Central diabetes insipidus
- Postoperative abdominal distension
- Bleeding esophageal varices
- Abdominal roentgenography
Find a Clinic Near You
Who Is Running the Clinical Trial?
Intermountain Health Care, Inc.
Lead Sponsor
University of Utah
Collaborator