NCT06503016

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

The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients: a Randomized Clinical Trial Protocol

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypotension
• Consciousness, Level Altered
• Airway Disease
• Respiratory Failure
• Tachypnea
• Bradypnea
• Tachycardia
• Bradycardia
• Cardiac Failure
• Cardiac Arrest

Interventions

Type	Name	Description
DRUG	Phosphocreatine	Administration of Phosphocreatine
DRUG	Placebo	Saline solution of NaCl 0.9%

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-04-01
• Completion: 2026-07-01
• First posted: 2024-07-16
• Last updated: 2025-08-06

Locations

1 site across 1 country: Italy