Early Versus Late Adjunctive Vasopressin in Septic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vasopressin - early initiation, vasopressin - standard initiation.
- Who it may be relevant to
- Registry conditions: Sepsis, Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock
Overview
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
- Drug vasopressin - early initiation
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min - Drug vasopressin - standard initiation
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min
Primary outcome measures
- Norepinephrine-equivalent dose [Time frame: Outcome evaluated on day of vasopressin initiation]
Secondary outcome measures (1)
- Proportion of patients within goal norepinephrine-equivalent dose range [Time frame: Outcome evaluated on day of vasopressin initiation]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Publications
- 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. PMID 34582425
Identifiers
NCT: NCT06709573 · 24-547