Clinical trial NCT06503016: The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients
Official title: The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients: a Randomized Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypotension
Consciousness, Level Altered
Airway Disease
Respiratory Failure
Tachypnea
Bradypnea
Tachycardia
Bradycardia
Cardiac Failure
Cardiac Arrest
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
Collaborators: name: Silvia Ajello
First posted: 2024-07-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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 criteria: 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 outcomes:
measure: days alive and out of hospital at 30 days.
timeFrame: day 30 or hospital discharge
Secondary outcomes:
measure: Cognitive function
timeFrame: day 30
measure: Rate of arrhythmia needing treatment
timeFrame: hospital discharge (which usually occurs in the 30days after randomization)
measure: Rate of ICU admissions or criteria for ICU admission
timeFrame: hospital discharge (which usually occurs in the 30days after randomization)
measure: Death at 30 days
timeFrame: day 30
measure: Death at 90 days
timeFrame: 90 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
References:
citation: Landoni G, Zangrillo A, Lomivorotov VV, Likhvantsev V, Ma J, De Simone F, Fominskiy E. Cardiac protection with phosphocreatine: a meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Oct;23(4):637-46. doi: 10.1093/icvts/ivw171. Epub 2016 Jun 17.
citation: Mingxing F, Landoni G, Zangrillo A, Monaco F, Lomivorotov VV, Hui C, Novikov M, Nepomniashchikh V, Fominskiy E. Phosphocreatine in Cardiac Surgery Patients: A Meta-Analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):762-770. doi: 10.1053/j.jvca.2017.07.024. Epub 2017 Jul 24.