Clinical trial NCT06709573: Early Versus Late Adjunctive Vasopressin in Septic Shock
Official title: Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Sepsis
Septic Shock
Keywords: Sepsis
Septic Shock
Vasopressors
Vasopressin
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Norepinephrine-equivalent dose
timeFrame: Outcome evaluated on day of vasopressin initiation
Secondary outcomes:
measure: Proportion of patients within goal norepinephrine-equivalent dose range
timeFrame: Outcome evaluated on day of vasopressin initiation
Other outcomes:
measure: Hemodynamic Response
timeFrame: 6 hours after vasopressin initiation
measure: ICU mortality
timeFrame: Through hospitalization admission
measure: In-hospital mortality
timeFrame: Through hospitalization admission
measure: BPA response rates
timeFrame: between the time of study enrollment and vasopressin initiation
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Gretchen L. Sacha, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sacha GL, Lam SW, Wang L, Duggal A, Reddy AJ, Bauer SR. Association of Catecholamine Dose, Lactate, and Shock Duration at Vasopressin Initiation With Mortality in Patients With Septic Shock. Crit Care Med. 2022 Apr 1;50(4):614-623. doi: 10.1097/CCM.0000000000005317.