The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients

Launched by UNIVERSITÀ VITA-SALUTE SAN RAFFAELE · Jul 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a substance called phosphocreatine (PCr) on patients who experience serious health issues that require urgent medical attention, known as Medical Emergency Team (MET) interventions. The researchers believe that adding PCr to standard treatments could help patients stay out of the hospital longer and improve their overall health during recovery. They are particularly interested in how PCr might reduce hospital stays and improve survival rates in patients with heart problems or respiratory issues.

To be eligible for the trial, participants need to be at least 18 years old, currently hospitalized but not in the intensive care unit (ICU), and have certain health conditions that prompted the MET to be called. This includes issues like very low blood pressure or significant changes in alertness. Participants will receive either PCr or a placebo (a treatment that has no active medication) in addition to their regular care. It’s important to know that there are specific criteria that might prevent someone from joining the trial, such as certain kidney problems or being pregnant. Overall, this study aims to find out if PCr can make a noticeable difference in the recovery of patients facing critical health challenges.

Gender

ALL

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.