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

NCT06503016 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-08-06

No results posted yet for this study

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.

Conditions

  • Hypotension
  • Consciousness, Level Altered
  • Airway Disease
  • Respiratory Failure
  • Tachypnea
  • Bradypnea
  • Tachycardia
  • Bradycardia
  • Cardiac Failure
  • Cardiac Arrest

Interventions

DRUG

Phosphocreatine

Administration of Phosphocreatine

DRUG

Placebo

Saline solution of NaCl 0.9%

Sponsors & Collaborators

  • Silvia Ajello

    collaborator UNKNOWN

  • Università Vita-Salute San Raffaele

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2026-04-30
Completion
2026-07-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06503016 on ClinicalTrials.gov