NCT06503016 The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients
| NCT ID | NCT06503016 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Università Vita-Salute San Raffaele |
| Condition | Hypotension |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2024-10-08 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06503016 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06503016 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06503016 currently recruiting?
Yes, NCT06503016 is actively recruiting participants. Contact the research team at landoni.giovanni@hsr.it for enrollment information.
Where is the NCT06503016 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06503016 clinical trial?
NCT06503016 is sponsored by Università Vita-Salute San Raffaele. The trial plans to enroll 400 participants.