The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phosphocreatine, Placebo.
- Who it may be relevant to
- Registry conditions: Hypotension, Consciousness, Level Altered, Airway Disease, Respiratory Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients: a Randomized Clinical Trial Protocol
Overview
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.
Interventions
- Drug Phosphocreatine
Administration of Phosphocreatine - Drug Placebo
Saline solution of NaCl 0.9%
Primary outcome measures
- days alive and out of hospital at 30 days. [Time frame: day 30 or hospital discharge]
Secondary outcome measures (5)
- Cognitive function [Time frame: day 30]
- Rate of arrhythmia needing treatment [Time frame: hospital discharge (which usually occurs in the 30days after randomization)]
- Rate of ICU admissions or criteria for ICU admission [Time frame: hospital discharge (which usually occurs in the 30days after randomization)]
- Death at 30 days [Time frame: day 30]
- Death at 90 days [Time frame: 90 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- IRCCS San Raffaele Scientific Institute — Milan
Publications
- Landoni G, Zangrillo A, Lomivorotov VV, Likhvantsev V, Ma J, De Simone F, Fominskiy E. Cardiac protection with phosphocreatine: a meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Oct;23(4):637-46. doi: 10.1093/icvts/ivw171. Epub 2016 Jun 17. PMID 27318357
- Mingxing F, Landoni G, Zangrillo A, Monaco F, Lomivorotov VV, Hui C, Novikov M, Nepomniashchikh V, Fominskiy E. Phosphocreatine in Cardiac Surgery Patients: A Meta-Analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):762-770. doi: 10.1053/j.jvca.2017.07.024. Epub 2017 Jul 24. PMID 29409711
Identifiers
NCT: NCT06503016 · GR-2021-12375001