A Phase 4 interventional study of vasopressin - early initiation and vasopressin - standard initiation in Sepsis and Septic Shock, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Treatment
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.
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 300 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min
Drug: vasopressin - early 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
Drug: vasopressin - standard initiation
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min
Also known as: vasopressin
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min
Also known as: vasopressin
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 initiation
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 initiation
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 initiation
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 admission
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 admission
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 initiation
Plan to share: No
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Studies of the drug tested here: Arginine Vasopressin