NCT06709573 Early Versus Late Adjunctive Vasopressin in Septic Shock
| NCT ID | NCT06709573 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Cleveland Clinic |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2025-04-29 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Gretchen L. Sacha, PharmD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06709573 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06709573 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06709573 currently recruiting?
Yes, NCT06709573 is actively recruiting participants. Contact the research team at sachag@ccf.org for enrollment information.
Where is the NCT06709573 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06709573 clinical trial?
NCT06709573 is sponsored by The Cleveland Clinic. The principal investigator is Gretchen L. Sacha, PharmD at The Cleveland Clinic. The trial plans to enroll 300 participants.