Status:
RECRUITING
The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients
Lead Sponsor:
Università Vita-Salute San Raffaele
Collaborating Sponsors:
Silvia Ajello
Conditions:
Hypotension
Consciousness, Level Altered
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 trigg...
Eligibility Criteria
Inclusion
- Admitted in hospital (but outside ICU)
- Age\>=18 years
- Written informed consent
- Serum creatinine \<=2 mg/dl
- Patient with impending or underlying cardiac failure or cardiac arrest, irrespectively of the primitive organ failure, and the Medical Emergency Team (MET) is called upon at least one of the following:
- Threatened airways;
- Respiratory arrest;
- Respiratory rate \<5 or \>36 breaths per min;
- Pulse rate \<40 or \>140 beats per min;
- Systolic blood pressure \< 90 mm Hg;
- Sudden fall in level of consciousness;
- Fall in Glasgow coma scale of \> 2 points.
Exclusion
- Age \< 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;
- Solitary kidney (by any reason);
- Serum Creatinine \> 2 mg/dl;
- Immediate need for ICU admission;
- Known allergy to PCr;
- Pregnancy;
- Previous enrollment and randomization into this trial;
- Administration of PCr in the previous 30 day.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06503016
Start Date
October 8 2024
End Date
July 1 2026
Last Update
August 6 2025
Active Locations (1)
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1
IRCCS San Raffaele Scientific Institute
Milan, Italy, 20132