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The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients

Study acronym: SPHERE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 6, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor 3 versions Re-verified since Dec 4, 2024, no change to tracked fieldsv3-v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2024 to Oct 8, 2024
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Unexpected deaths and unplanned intensive care unit (ICU) admissions are common during hospital stay and are often preceded by warning abnormalities in patients' vital signs. These abnormalities trigger Medical Emergency Team (MET) activation and up to 15% of patients visited by the MET is admitted to the ICU with an overall hospital stay after the MET intervention of approximately 2 weeks. Phosphocreatine (PCr) is a natural energy-buffering molecule associated with signals of mortality reduction in patients with acute cardiac conditions (according to meta-analytic finding from our group) and with encouraging beneficial effects on other acute organ failures (e.g. brain). The investigators designed a multi-center, randomized, placebo-controlled trial to confirm the promising beneficial effects of PCr in hospitalized patients. The investigators expects a reduction in hospital stay (measured as an increase in days alive and out of hospital at 30 days) when PCr is added to standard treatment in patients requiring MET intervention.
Trial Details
NCT Number NCT06503016
Lead Sponsor Università Vita-Salute San Raffaele
Collaborators: Silvia Ajello
Conditions
(from sponsor)
Hypotension, Consciousness, Level Altered, Airway Disease, Respiratory Failure, Tachypnea, Bradypnea, Tachycardia, Bradycardia +2 more
Related terms Bradycardia, Consciousness Disorders, Heart Arrest, Heart Failure, Hypotension, Hypoventilation, Respiratory Insufficiency, Tachycardia, Tachypnea
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov