Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06503016

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Age < 18 years;
  • Ongoing cardiac massage;
  • Current hospital admission from a care nursing facility;
  • Planned discharge to a care nursing facility;
  • Reasons for withdrawal of life-sustaining therapy;
  • History of kidney transplantation;
  • Solitary kidney (by any reason);
  • Serum Creatinine > 2 mg/dl;
  • Immediate need for ICU admission;
  • Known allergy to PCr;
  • Pregnancy;
  • Previous enrollment and randomization into this trial;
  • Administration of PCr in the previous 30 day.

Treatment and study plan

Phosphocreatine

Drug

Administration of Phosphocreatine

Placebo

Drug

Saline solution of NaCl 0.9%

Primary outcomes

  1. days alive and out of hospital at 30 days.

    Time frame: day 30 or hospital discharge

    To compare the effect of phosphocreatine (PCr) (experimental group), versus placebo (saline solution-control group) on the number of days alive and out of hospital at 30 days.

Secondary outcomes

  1. Cognitive function

    Time frame: day 30

    Evaluation of cognitive function using the Cognitive Telephone Screening Instrument (COGTEL). The COGTEL is a test that evaluates the cognitive performance of survived patients 30 days after randomization. This scale has a minimum of zero points and a maximum of 100.

  2. Rate of arrhythmia needing treatment

    Time frame: hospital discharge (which usually occurs in the 30days after randomization)

    Clinically relevant arrhythmias will be recorded and confirmed by an ECG. Rate of major arrhythmias divided into supraventricular arrhythmias, ventricular arrhythmias, bradyarrhythmias, and need for antiarrhythmics will be registered.

  3. Rate of ICU admissions or criteria for ICU admission

    Time frame: hospital discharge (which usually occurs in the 30days after randomization)

    ICU admission

  4. Death at 30 days

    Time frame: day 30

    Death

  5. Death at 90 days

    Time frame: 90 days

    Death

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Landoni, Prof.

CONTACT

[email protected]

+39022643 ext. 6151

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Collaborators

  • Silvia Ajello

Registry information

Official study title

The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients: a Randomized Clinical Trial Protocol

Acronym: SPHERE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2024
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.