Actively Recruiting
The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients
Led by Università Vita-Salute San Raffaele · Updated on 2025-08-06
400
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
Sponsors
U
Università Vita-Salute San Raffaele
Lead Sponsor
S
Silvia Ajello
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted in hospital but outside ICU
- Age 18 years or older
- Written informed consent given
- Serum creatinine level less than or equal to 2 mg/dl
- Patient has impending or underlying cardiac failure or cardiac arrest and MET is called for at least one of these: threatened airways, respiratory arrest, respiratory rate less than 5 or greater than 36 breaths per minute, pulse rate less than 40 or greater than 140 beats per minute, systolic blood pressure less than 90 mm Hg, sudden fall in consciousness level, or fall in Glasgow coma scale of more than 2 points
You will not qualify if you...
- Age under 18 years
- Ongoing cardiac massage
- Current hospital admission from a care nursing facility
- Planned discharge to a care nursing facility
- Reasons for withdrawal of life-sustaining therapy
- History of kidney transplantation
- Having a solitary kidney
- Serum creatinine level greater than 2 mg/dl
- Immediate need for ICU admission
- Known allergy to phosphocreatine
- Pregnancy
- Previous enrollment and randomization in this trial
- Administration of phosphocreatine in the previous 30 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Scientific Institute
Milan, Italy, 20132
Actively Recruiting
Research Team
G
Giovanni Landoni, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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