Early Versus Late Adjunctive Vasopressin in Septic Shock
NCT06709573 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-03-12
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.
Conditions
- Sepsis
- Septic Shock
Interventions
- DRUG
-
vasopressin - early initiation
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min
- DRUG
-
vasopressin - standard initiation
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min
Sponsors & Collaborators
-
The Cleveland Clinic
lead OTHER
Principal Investigators
-
Gretchen L. Sacha, PharmD · The Cleveland Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-29
- Primary Completion
- 2026-05-01
- Completion
- 2026-05-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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