Early versus standard timing of vasopressin for adults with septic shock
Official title: Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock
Run by The Cleveland Clinic · NCT06709573 · Data updated 2026-11-12
This pilot tests whether starting vasopressin earlier versus at the usual time helps adults with septic shock who are receiving norepinephrine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | April 29, 2025 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT06709573 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with a diagnosis of septic shock admitted to the Cleveland Clinic Main Campus Medical ICU who are receiving a continuous norepinephrine infusion and meet enrollment criteria are eligible.
✕Probably not a fit
Patients not in the Cleveland Clinic Medical ICU, those already receiving other vasoactive agents besides norepinephrine at enrollment, or those whose care is altered before the CDS fires may not receive benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot uses clinical decision support (CDS) built into the Epic electronic health record to randomize adults with septic shock in a medical ICU to early or standard initiation of adjunctive vasopressin based on norepinephrine dose. Eligible patients are adults admitted to the Cleveland Clinic Main Campus Medical ICU who are receiving a continuous norepinephrine infusion above a prespecified threshold. The primary aim is to show the CDS can create two distinct cohorts reflecting different norepinephrine doses at the time vasopressin is started, and secondary aims include measuring adherence to the CDS and comparing clinical outcomes between arms. The trial is a Phase 4 feasibility pilot focused on workflow integration and fidelity rather than definitive efficacy outcomes.
Why it matters
Potential benefit: If successful, this approach could lead to clearer guidance on when to add vasopressin and more consistent use across patients, potentially improving blood pressure control and clinical outcomes.
How similar studies have gone: Observational studies and guideline statements have suggested timing windows for vasopressin, but randomized, CDS-driven comparisons of early versus standard initiation are limited, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Cleveland Clinic
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Gretchen L. Sacha, PharmD — The Cleveland Clinic
- Study coordinator: Gretchen L. Sacha, PharmD
- Email: sachag@ccf.org
- Phone: 216-379-4237
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.