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Recruiting
NCT06709573
Early Versus Late Adjunctive Vasopressin in Septic Shock
Conditions: Sepsis, Septic Shock
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 300
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Cleveland Ohio
Summary
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
Inclusion Criteria:
* Age ≥ 18 Years
* Diagnosis of Septic Shock
* Admitted to Cleveland Clinic Main Campus Medical ICU
* Receiving continuous infusion of norepinephrine at a dose \> 5 mcg/min at time of enrollment
Exclusion Criteria:
* Administration of any other vasoactive agent other than norepinephrine at time of enrollment
* Initiation of vasopressin by provider outside of the context of study when NE \< 10 mcg/min (before BPA firing)
Source: ClinicalTrials.gov (NCT06709573). StuddyBuddy aggregates publicly available trial information.