NCT06503016RecruitingPhase 3
The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients
The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients: a Randomized Clinical Trial Protocol
Source: ClinicalTrials.gov · Last updated 6 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 5 Jul 2024
- Start date
- 8 Oct 2024
- Primary completion date
- Apr 2026
- Lead sponsor
- Università Vita-Salute San Raffaele
- Diseases
- Heart failure
- NCT number
- NCT06503016
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 8 Oct 2024 to the primary completion date, Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Reasons for withdrawal of life-sustaining therapy;
- Previous enrollment and randomization into this trial;
- Administration of PCr in the previous 30 day.
Other illness
- Ongoing cardiac massage;
- History of kidney transplantation;
- Known allergy to PCr;
Lab values
- Serum Creatinine \> 2 mg/dl;
Age
- Age \< 18 years;
Other
- Current hospital admission from a care nursing facility;
- Planned discharge to a care nursing facility;
- Solitary kidney (by any reason);
- Immediate need for ICU admission;
- Pregnancy;
Who the study is looking for
- Admitted in hospital (but outside ICU)
- Age\>=18 years
- Written informed consent
- Serum creatinine \<=2 mg/dl
- 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:
- Threatened airways;
- Respiratory arrest;
- Respiratory rate \<5 or \>36 breaths per min;
- Pulse rate \<40 or \>140 beats per min;
- Systolic blood pressure \< 90 mm Hg;
- Sudden fall in level of consciousness;
- Fall in Glasgow coma scale of \> 2 points.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Scientific Institute Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.