Recruiting

Vasopressin vs. Standard Care

Sponsor:

The Cleveland Clinic

Code:

NCT06709573

Conditions

Sepsis

Septic Shock

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

vasopressin - early initiation

vasopressin - standard initiation

Study Details

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.

Conditions

Sepsis

Septic Shock

Study ID

NCT06709573

Start date

Apr 29, 2025

Status verified date

Aug, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early Vasopressin Initiation

Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min

active comparator: Standard of Care Vasopressin 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

Interventions

vasopressin - early initiation

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

vasopressin - standard initiation

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

Primary outcome measure

  • Norepinephrine-equivalent dose [ Time Frame: Outcome evaluated on day of vasopressin initiation ]

Central Contacts and Locations

Central contacts

Gretchen L. Sacha, PharmD

216-379-4237sachag@ccf.org

Abhijit Duggal, MD

216-444-4838duggala2@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44095

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Sepsis
  • Septic Shock
  • Vasopressors
  • Vasopressin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-08-31.