Effect of phosphocreatine on patients treated by medical emergency teams

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of phosphocreatine (PCr) on hospitalized patients who experience critical conditions requiring intervention from medical emergency teams. It is a multi-center, randomized, placebo-controlled phase 3 trial aimed at confirming the beneficial effects of PCr in reducing hospital stays and improving patient outcomes. The study focuses on patients with impending cardiac failure or other acute conditions that trigger MET activation. By comparing the outcomes of patients receiving PCr versus a placebo, the trial seeks to establish the efficacy of this natural energy-buffering molecule in enhancing recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS San Raffaele Scientific Institute
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Giovanni Landoni, Prof.
• Email: landoni.giovanni@hsr.it
• Phone: +39022643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.