Early Versus Late Adjunctive Vasopressin in Septic Shock

NCT ID: NCT06709573

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-29
• Study Completion Date: 2025-12-31

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.

Conditions

Sepsis; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

vasopressin - early initiation

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

vasopressin - standard initiation

Intervention Type: DRUG

BPA fires to provider 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

Intervention Type: DRUG

vasopressin - standard initiation

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

Intervention Type: DRUG

Other Intervention Names

vasopressin; vasopressin

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Gretchen Sacha

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gretchen L. Sacha, PharmD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gretchen L. Sacha, PharmD

Role: CONTACT

sachag@ccf.org

216-379-4237

Abhijit Duggal, MD

Role: CONTACT

duggala2@ccf.org

216-444-4838

References

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.

Reference Type: BACKGROUND

PMID: 34582425 (View on PubMed)

Other Identifiers

24-547

Identifier Type: -

Identifier Source: org_study_id