Effect of phosphocreatine on patients treated by medical emergency teams
The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients: a Randomized Clinical Trial Protocol
This study tests if giving phosphocreatine to hospitalized patients with serious conditions can help them recover faster and shorten their hospital stays compared to those who receive a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06503016 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 18 and older with impending cardiac failure or other acute conditions requiring MET intervention.
Not a fit: Patients currently in the ICU or those with severe renal impairment or other critical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce hospital stays and improve survival rates for patients experiencing acute medical emergencies.
How similar studies have performed: Previous studies have indicated promising results for phosphocreatine in acute cardiac conditions, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan
- IRCCS San Raffaele Scientific Institute — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Landoni, Prof.
- Email: landoni.giovanni@hsr.it
- Phone: +39022643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.