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Vasopressor

Septic shock treatment strategy involving a lower threshold for vasopressin initiation 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

VASSPR Trial 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.Check my eligibility

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.See study design

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.

VASSPR Trial 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.

VASSPR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

28-day all-cause mortality

Secondary outcome measures

Renal replacement therapy-free days to day 28

Other outcome measures

90-day all-cause mortality

Hospital-free days to day 28

In-hospital all-cause mortality

+13 more

VASSPR 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

Find a Location

Who is running the clinical trial?

University of UtahOTHER

1,098 Previous Clinical Trials

1,776,580 Total Patients Enrolled

Intermountain Health Care, Inc.Lead Sponsor

137 Previous Clinical Trials

1,961,060 Total Patients Enrolled

4 Trials studying Septic Shock

4,017 Patients Enrolled for Septic Shock

Ithan Peltan, MD, MScPrincipal InvestigatorIntermountain Health

1 Previous Clinical Trials

3,230 Total Patients Enrolled

1 Trials studying Septic Shock

3,230 Patients Enrolled for Septic Shock

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"According to the information provided on clinicaltrials.gov, this particular trial is no longer actively seeking participants. The initial posting date of this study was February 1st, 2024, with the most recent update occurring on January 18th, 2024. However, it's worth noting that there are currently a total of 152 other trials available for enrollment at this time."

Answered by AI

At how many distinct sites is this research study currently underway?

"At present, patient recruitment is underway at 13 different sites. These locations include Burley, Provo, and American Fork, among others. It is advised that prospective participants choose the site nearest to them in order to minimize travel requirements upon enrollment."

Answered by AI

Has the approach of initiating vasopressin at a lower threshold as part of the treatment strategy for septic shock received approval from the FDA?

"Given that this treatment strategy has already been approved and is now being evaluated in a Phase 4 trial, our team rates its safety as a 3 on the scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vasopressin for Septic Shock Pragmatic Trial

2024. "Vasopressin for Septic Shock Pragmatic Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06217562.