Early Versus Late Adjunctive Vasopressin in Septic Shock
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
vasopressin - early initiation
DrugBPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min
vasopressin - standard initiation
DrugBPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Early Vasopressin InitiationExperimental treatment 1 intervention
Group B: Standard of Care Vasopressin InitiationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Norepinephrine-equivalent dose
The primary outcome is the norepinephrine-equivalent dose (in mcg/min) at the time of vasopressin initiation between patients who were randomized by CDS to early adjunctive vasopressin initiation compare to late adjunctive vasopressin initiation
Time frame
Outcome evaluated on day of vasopressin initiationSecondary outcomes
1
Proportion of patients within goal norepinephrine-equivalent dose range
This outcome will evaluate the overall proportion of patients enrolled in the trial whose norepinephrine dose at the time of vasopressin is within the goal range for the treatment group (\< 20 mcg/min for the early vasopressin group and \> 20 mcg for the standard of care vasopressin)
Time frame
Outcome evaluated on day of vasopressin initiationOther outcomes
1
Hemodynamic Response
Compare rates of hemodynamic response to vasopressin initiation between patients who were randomized by CDS to early adjunctive vasopressin initiation compare to late adjunctive vasopressin initiation
Time frame
6 hours after vasopressin initiation2
ICU mortality
Compare ICU mortality between patients who were randomized by CDS to early adjunctive vasopressin initiation compare to late adjunctive vasopressin initiation
Time frame
Through hospitalization admission3
In-hospital mortality
Compare rates of in-hospital mortality between patients who were randomized by CDS to early adjunctive vasopressin initiation compare to late adjunctive vasopressin initiation
Time frame
Through hospitalization admission4
BPA response rates
Overall evaluate and describe BPA response: the proportion of patients who were initiated on vasopressin, time to vasopressin initiation after BPA firing, and provider documented rationale for not initiating vasopressin after BPA firing
Time frame
between the time of study enrollment and vasopressin initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov