RecruitingPhase 4NCT06709573

Early Versus Late Adjunctive Vasopressin in Septic Shock

Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock


Sponsor

The Cleveland Clinic

Enrollment

300 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria2

  • 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)

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Interventions

DRUGvasopressin - early initiation

BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min

DRUGvasopressin - standard initiation

BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT06709573


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