SepsisPhase 4CASPER-PilotNCT06709573
Early Versus Late Adjunctive Vasopressin in Septic Shock
A Phase 4 study testing vasopressin - early initiation and vasopressin - standard initiation in people with Sepsis and Septic Shock, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- vasopressin - early initiation and vasopressin - standard initiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2025to 1 May 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44095
About this study
Official title: Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock
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.
Read the 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
- Being tested
- vasopressin - early initiation, vasopressin - standard initiation
- Keywords
- Sepsis, Septic Shock, Vasopressors, Vasopressin
- Medical subject headings
- Sepsis, Shock, Septic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasopressin - early initiationDrug
Also called vasopressin
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min
vasopressin - standard initiationDrug
Also called vasopressin
BPA fires to provider prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min
| Study group | Role | What they receive |
|---|---|---|
| Early Vasopressin Initiation | Experimental | Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 10-20 mcg/min Receives: Drug: vasopressin - early initiation |
| Standard of Care Vasopressin Initiation | Active comparator | Patients randomized to this arm will have a provider BPA fire prompting vasopressin initiation when the norepinephrine dose is between 20-35 mcg/min Receives: Drug: vasopressin - standard initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Norepinephrine-equivalent dose
The primary outcome is the norepinephrine-equivalent dose (in mcg/min) at the time of vasopressin initiation between patients who were randomized by CDS to early adjunctive vasopressin initiation compare to late adjunctive vasopressin initiation
Measured: Outcome evaluated on day of vasopressin initiation
Secondary outcomes (1)
Proportion of patients within goal norepinephrine-equivalent dose range
This outcome will evaluate the overall proportion of patients enrolled in the trial whose norepinephrine dose at the time of vasopressin is within the goal range for the treatment group (< 20 mcg/min for the early vasopressin group and > 20 mcg for the standard of care vasopressin)
Measured: Outcome evaluated on day of vasopressin initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start29 Apr 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gretchen Sacha, The Cleveland Clinic
- Investigators
- Gretchen L. Sacha, PharmD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709573
- Sponsor's protocol ID
- 24-547
- Acronym
- CASPER-Pilot
- Status last verified
- Aug 2026
- First submitted
- 21 Nov 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34582425