RecruitingPhase 3NCT06503016

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

Sponsor

Università Vita-Salute San Raffaele

Enrollment

400 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (SPHERE) tests whether giving phosphocreatine — a natural compound that supports energy in heart muscle cells — during a medical emergency in hospitalized patients can help prevent cardiac arrest or death. **You may be eligible if...** - You are 18 or older - You are currently admitted to a hospital ward (not the ICU) - You are experiencing signs of a medical emergency where a rapid response team (MET) has been called — such as very low blood pressure, breathing problems, or sudden loss of consciousness - Your kidney function is acceptable (creatinine ≤ 2 mg/dL) **You may NOT be eligible if...** - You are currently receiving CPR (ongoing cardiac massage) - You were admitted from, or are being discharged to, a nursing care facility - You have reasons for withdrawal of life-sustaining treatment - You have had a kidney transplant or have only one kidney - You need immediate ICU transfer - You have a known allergy to phosphocreatine - You are pregnant - You have participated in this trial before - You have received phosphocreatine in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPhosphocreatine

Administration of Phosphocreatine

DRUGPlacebo

Saline solution of NaCl 0.9%

Locations(1)

IRCCS San Raffaele Scientific Institute

Milan, Italy

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NCT06503016

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