Current partner codePEPTIDESDE
NCT06709573·Phase 4·INTERVENTIONAL

Early Versus Late Adjunctive Vasopressin in Septic Shock

Status

Recruiting

Phase

Phase 4

Enrollment

300

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Nov 29, 2024

  2. Study start

    Apr 29, 2025

  3. Primary completion

    May 1, 2026

  4. Study completion

    May 1, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Mar 12, 2026

Outcomes

What the study measures.

Primary outcomes

Norepinephrine-equivalent dose

Time frame · 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 outcomes

Proportion of patients within goal norepinephrine-equivalent dose range

Time frame · 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)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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)

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Cleveland Clinic

Cleveland, Ohio, United States

Related trials

More studies on Vasopressin.

Related PeptideStat pages

Put the record in context.

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