Sepsis, Septic Shock
Conditions
Keywords
Sepsis, Septic Shock, Vasopressors, Vasopressin
Brief 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.
Detailed description
Sepsis is a highly prevalent and morbid disease estimated to account for up to 20% of annual deaths globally. If not rapidly identified and intervened upon, patients with sepsis may progress to septic shock, which is associated with mortality rates up to 50%. Patients with septic shock have persistent hypotension requiring vasoactive agents to augment blood pressure despite fluid resuscitation. Norepinephrine is recommended first-line by the Surviving Sepsis Campaign (SSC) guidelines for patients with septic shock. If mean arterial pressure (MAP) remains inadequate on norepinephrine, vasopressin is suggested as the second-line adjunctive agent. Over 30% of patients with septic shock in the United States (US) receive adjunctive vasopressin, with use rising over time. Despite increased use over time, ideal patient selection and initiation timing for adjunctive vasopressin in the course of a patient's shock are not well elucidated. The 2021 iteration of the SSC guidelines note that initiating vasopressin when the patient requires between 0.25 and 0.5 mcg/kg/min of norepinephrine "seems sensible". Yet, many questions remain regarding the timing of vasopressin initiation. The goal of this proposal is to evaluate the timing of vasopressin initiation in patients with septic shock based on the norepinephrine requirements at the time of vasopressin initiation. This pilot study will attempt to develop CDS technology in which to answer this clinical question.
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
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Norepinephrine-equivalent dose | Outcome evaluated on day of vasopressin initiation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients within goal norepinephrine-equivalent dose range | Outcome evaluated on day of vasopressin initiation | 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) |
Countries
United States
Contacts
CONTACTGretchen L. Sacha, PharmD
CONTACTAbhijit Duggal, MD
PRINCIPAL_INVESTIGATORGretchen L. Sacha, PharmD
The Cleveland Clinic
Outcome results
None listed