Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06709573

Early Versus Late Adjunctive Vasopressin in Septic Shock

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

vasopressin - early initiation

Drug

BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min

Other names: vasopressin

vasopressin - standard initiation

Drug

BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min

Other names: vasopressin

Primary outcomes

  1. 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

  1. 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)

Other outcomes

  1. Hemodynamic Response

    Time frame: 6 hours after vasopressin initiation

    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

  2. ICU mortality

    Time frame: Through hospitalization admission

    Compare ICU mortality between patients who were randomized by CDS to early adjunctive vasopressin initiation compare to late adjunctive vasopressin initiation

  3. In-hospital mortality

    Time frame: Through hospitalization admission

    Compare rates of in-hospital mortality between patients who were randomized by CDS to early adjunctive vasopressin initiation compare to late adjunctive vasopressin initiation

  4. BPA response rates

    Time frame: between the time of study enrollment and vasopressin initiation

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Abhijit Duggal, MD

CONTACT

[email protected]

216-444-4838

Gretchen L. Sacha, PharmD

CONTACT

[email protected]

216-379-4237

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock

Acronym: CASPER-Pilot

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.