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Early Versus Late Adjunctive Vasopressin in Septic Shock

Study acronym: CASPER-Pilot
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later May 1, 2026 → May 1, 2027
See other at-risk trials from The Cleveland Clinic

Record History

  1. Primary and study completion pushed from May 1, 2026 to May 1, 2027v5
  2. Primary completion date: Dec 1, 2025 to May 1, 2026
    • Study completion date: Dec 31, 2025 to May 1, 2026
    • Publications: details revised at 1 of 1 entry
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2025 to Apr 29, 2025
    • Site details revised
    v3
  4. Start date: Jan 1, 2025 to Mar 1, 2025v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06709573
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Sepsis, Septic Shock
Related terms Diabetes Insipidus, Sepsis, Shock, Septic
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov