What this study is
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.
What's being tested
- vasopressin - early initiation
Intervention · DRUG
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min
- vasopressin - standard initiation
Intervention · DRUG
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min
Study details
- Official title
- Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock
- Sponsor
- The Cleveland Clinic
- Conditions
- Sepsis · Septic Shock
- Enrolling
- 300 people
- Starts
- 2025-04-29
- Est. completion
- 2027-05-01
- Design
- Double-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openCleveland Clinic
Cleveland, Ohio, United States
Recruiting
Study team
Sponsor
The Cleveland Clinic
Study ID 24-547
Principal investigator
Gretchen L. Sacha, PharmD
The Cleveland Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.