Vasopressin Timing for Septic Shock

(CASPER-Pilot Trial)

Overseen By Gretchen L. Sacha, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cleveland Clinic

Must be taking: Norepinephrine

Must not be taking: Other vasoactive agents

Disqualifiers: Vasopressin initiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of hospitalization

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to determine when to start vasopressin, a drug used to raise blood pressure, for individuals with septic shock. This serious condition results from an infection that causes dangerously low blood pressure. The researchers aim to assess whether technology-guided timing of vasopressin can improve treatment outcomes. Participants will be divided into two groups: one starts vasopressin earlier, and the other follows standard timing. Suitable candidates have septic shock, are in the Cleveland Clinic ICU, and are already receiving norepinephrine, another medication to raise blood pressure. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients, offering an opportunity to contribute to improving care for septic shock.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be on any other vasoactive agents besides norepinephrine when you join the study.

What is the safety track record for vasopressin?

Research has shown that vasopressin is generally safe for humans. In earlier studies, starting vasopressin treatment early in patients with septic shock linked to less organ failure and lower death rates. Additionally, no major side effects occurred when vasopressin was administered sooner rather than later. This suggests that vasopressin is safe for use in critical care, including for those with septic shock. Please note, this trial focuses on the timing of vasopressin administration, not on the drug's safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about the Vasopressin Timing for Septic Shock trial because it explores whether the timing of vasopressin initiation can make a difference in treating septic shock. While the standard of care typically starts vasopressin when norepinephrine doses are higher (20-35 mcg/min), this trial investigates starting it earlier, between 10-20 mcg/min. This approach could potentially stabilize patients more quickly and reduce the severity of septic shock symptoms. By testing this timing, researchers hope to optimize treatment effectiveness and improve outcomes for patients.

What evidence suggests that this trial's treatments could be effective for septic shock?

This trial will compare the timing of vasopressin initiation in patients with septic shock. Research has shown that starting vasopressin earlier can be very helpful. For example, one study found that using vasopressin sooner reduced the number of deaths in the hospital. Another study showed that early use of vasopressin shortened hospital stays by about 4.5 days. However, some research suggests that while early vasopressin can reduce hospital time, it might not significantly change the time spent in the intensive care unit or the overall duration of medication use to raise blood pressure. Overall, early vasopressin use seems promising, but results can vary based on specific conditions and timing. Participants in this trial will be randomized to either early vasopressin initiation or standard of care vasopressin initiation to further investigate these findings. ^{2 3 4 6 7}

Who Is on the Research Team?

Gretchen L. Sacha, PharmD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients with septic shock, a severe infection leading to dangerously low blood pressure. Participants must meet specific criteria not disclosed here.

Inclusion Criteria

I have been diagnosed with septic shock.

I am admitted to the Cleveland Clinic Main Campus Medical ICU.

I am on a continuous norepinephrine infusion at more than 5 mcg/min.

Exclusion Criteria

I am not taking any blood pressure medications other than norepinephrine.

I was given vasopressin for my condition before the study, with low NE levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to early or standard of care vasopressin initiation based on norepinephrine dose requirements

Duration of hospitalization

Continuous monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

Through hospitalization admission

Outcome Evaluation

Evaluation of norepinephrine-equivalent dose, ICU mortality, in-hospital mortality, and hemodynamic response

6 hours to end of hospitalization

What Are the Treatments Tested in This Trial?

Interventions

• Vasopressin

Trial Overview The study tests if clinical decision support technology can help start vasopressin treatment early versus the standard timing based on norepinephrine dose needs in septic shock patients.

How Is the Trial Designed?

Group I: Early Vasopressin Initiation Experimental Treatment 1 Intervention

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 II: Standard of Care Vasopressin Initiation Active Control 1 Intervention

Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12070644/

Effect of early adjunctive vasopressin initiation for septic ... The primary outcome of this study was 30-day ICU mortality. Subgroup analyses were conducted to test the interaction of early vasopressin start with peak ...

2. chestphysician.org chestphysician.org/study-shows-earlier-vasopressin-initiation-for-sepsis-reduced-in-hospital-mortality/

Study shows earlier vasopressin initiation for sepsis reduced ... Clinicians initiated vasopressin in 31% of patients at a median SOFA score of 9 a median of five hours after shock onset with a norepinephrine ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675725006643

Early vasopressin plus norepinephrine versus delayed or ... Early vasopressin reduced hospital stay by 4.5 days in septic shock patients. · No significant effect on ICU stay, SOFA score, or vasopressor duration. · Early ...

4. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-025-05540-2

Vasopressin and its analogues in patients with septic shock Nevertheless, the use of vasopressin in patients with septic shock has not yet demonstrated clear benefits in terms of patient outcomes, such as ...

5. annalsofintensivecare.springeropen.com annalsofintensivecare.springeropen.com/articles/10.1186/s13613-025-01428-0

Extremely early initiation of vasopressors might not decrease ... Studies comparing early and late vasopressor administration in septic shock patients were included. The primary outcome was short-term mortality ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12592957/

Timing of Vasopressin Initiation in Patients with Septic Shock Early initiation of vasopressin was associated with a lower short-term mortality [relative risk (RR) 0.84, 95% CI: 0.71–0.99; p = 0.033, I = ...

7. journals.lww.com journals.lww.com/ccejournal/fulltext/2025/09000/vasopressin_initiation_timing_and_in_hospital.1.aspx

Vasopressin Initiation Timing and In-Hospital Mortality in... Finally, the odds of in-hospital mortality increased by 3% for every hour in the time duration from shock onset to vasopressin initiation (adjusted OR, 1.03 [95 ...