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.
Admitted in hospital (but outside ICU)
Age>=18 years
Written informed consent
Serum creatinine <=2 mg/dl
Age < 18 years;
Ongoing cardiac massage;
Current hospital admission from a care nursing facility;
Planned discharge to a care nursing facility;
Parallel
Phosphocreatine
DrugAdministration of Phosphocreatine
Placebo
DrugSaline solution of NaCl 0.9%
days alive and out of hospital at 30 days.
To compare the effect of phosphocreatine (PCr) (experimental group), versus placebo (saline solution-control group) on the number of days alive and out of hospital at 30 days.
Cognitive function
Evaluation of cognitive function using the Cognitive Telephone Screening Instrument (COGTEL). The COGTEL is a test that evaluates the cognitive performance of survived patients 30 days after randomization. This scale has a minimum of zero points and a maximum of 100.
Rate of arrhythmia needing treatment
Clinically relevant arrhythmias will be recorded and confirmed by an ECG. Rate of major arrhythmias divided into supraventricular arrhythmias, ventricular arrhythmias, bradyarrhythmias, and need for antiarrhythmics will be registered.
Rate of ICU admissions or criteria for ICU admission
ICU admission
Death at 30 days
Death
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Università Vita-Salute San Raffaele
Lead sponsor
Silvia Ajello
Collaborator
