Early Versus Late Adjunctive Vasopressin in Septic Shock

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06709573
Phase
PHASE4
Status
Recruiting
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Conditions

  • Sepsis
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vasopressin - early initiation — DRUG
    BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min
  • vasopressin - standard initiation — DRUG
    BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min

Study Details

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.

Key Dates

Start date
Apr 29, 2025
Status verified
Mar 2026
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early Vasopressin Initiation
    Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min
  • Active Comparator: Standard of Care Vasopressin Initiation
    Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min

Primary Outcome Measure

Norepinephrine-equivalent dose [ Time Frame: Outcome evaluated on day of vasopressin initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44095-

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