Vasopressin Timing for Septic Shock
(CASPER-Pilot Trial)

Recruiting in Palo Alto (17 mi)

Overseen byGretchen L. Sacha, PharmD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: The Cleveland Clinic

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of the CASPER-Pilot study is to develop clinical decision support (CDS) technology within Epic to randomize patients with septic shock to early versus standard of care vasopressin initiation. The primary aim of this study will be to test the hypothesis that CDS technology can be utilized to create two distinct cohorts of patients reflecting different times of vasopressin initiation based on norepinephrine dose requirements. Secondarily, this study will evaluate the proportion of patients whose norepinephrine dose at the time of vasopressin initiation is within the specified range for the intervention arm they were randomized to. Other outcomes of evaluation will include adherence to the developed CDS technology and comparison of clinical outcomes between the two treatment arms.

Eligibility Criteria

This trial is for patients with septic shock, a severe infection leading to dangerously low blood pressure. Participants must meet specific criteria not disclosed here.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with septic shock.

I am admitted to the Cleveland Clinic Main Campus Medical ICU.

See 1 more

Exclusion Criteria

I am not taking any blood pressure medications other than norepinephrine.

I was given vasopressin for my condition before the study, with low NE levels.

Treatment Details

Interventions

Vasopressin (Vasopressor)

Trial OverviewThe study tests if clinical decision support technology can help start vasopressin treatment early versus the standard timing based on norepinephrine dose needs in septic shock patients.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Early Vasopressin InitiationExperimental Treatment1 Intervention

Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min

Group II: Standard of Care Vasopressin InitiationActive Control1 Intervention

Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min