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Vasopressin Timing for Septic Shock (CASPER-Pilot Trial)
Phase 4
Waitlist Available
Led By Gretchen L. Sacha, PharmD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 Years
Admitted to Cleveland Clinic Main Campus Medical ICU
Must not have
Administration of any other vasoactive agent other than norepinephrine at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between the time of study enrollment and vasopressin initiation
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial aims to use technology to help doctors decide when to start a medication called vasopressin in patients with septic shock. They will use a system to randomly assign patients to receive vasop
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Vasopressin may cause side effects like abnormal heart rhythms, decreased cardiac output, and allergic reactions. The exact side effects will depend on individual patient responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am admitted to the Cleveland Clinic Main Campus Medical ICU.
Select...
I have been diagnosed with septic shock.
Select...
I am on a continuous norepinephrine infusion at more than 5 mcg/min.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any blood pressure medications other than norepinephrine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome evaluated on day of vasopressin initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome evaluated on day of vasopressin initiation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Norepinephrine-equivalent dose
Secondary study objectives
Proportion of patients within goal norepinephrine-equivalent dose range
Other study objectives
BPA response rates
Hemodynamic Response
ICU mortality
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Vasopressin InitiationExperimental Treatment1 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 InitiationActive Control1 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
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,460 Total Patients Enrolled
6 Trials studying Sepsis
542 Patients Enrolled for Sepsis
Gretchen L. Sacha, PharmDPrincipal InvestigatorThe Cleveland Clinic