Phosphocreatine: Administration of Phosphocreatine
Placebo: Saline solution of NaCl 0.9%
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Admitted in hospital (but outside ICU)
2. Age\>=18 years
3. Written informed consent
4. Serum creatinine \<=2 mg/dl
5. 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:
1. Threatened airways;
2. Respiratory arrest;
3. Respiratory rate \<5 or \>36 breaths per min;
4. Pulse rate \<40 or \>140 beats per min;
5. Systolic blood pressure \< 90 mm Hg;
6. Sudden fall in level of consciousness;
7. Fall in Glasgow coma scale of \> 2 points.
Exclusion Criteria:
1. Age \< 18 years;
2. Ongoing cardiac massage;
3. Current hospital admission from a care nursing facility;
4. Planned discharge to a care nursing facility;
5. Reasons for withdrawal of life-sustaining therapy;
6. History of kidney transplantation;
7. Solitary kidney (by any reason);
8. Serum Creatinine \> 2 mg/dl;
9. Immediate need for ICU admission;
10. Known allergy to PCr;
11. Pregnancy;
12. Previous enrollment and randomization into this trial;
13. Administration of PCr in the previous 30 day.
Primary outcome measure(s)
days alive and out of hospital at 30 days. — day 30 or hospital discharge 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.
Trial sites (1)
Facility
City
Region
Status
IRCCS San Raffaele Scientific Institute
Milan
Italy
Recruiting
More Università Vita-Salute San Raffaele trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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