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| Name | Class |
|---|---|
| Silvia Ajello | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phosphocreatine | Experimental | Patients randomized to the phosphocreatine group will receive the drug for a maximum of 3 days.
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| Placebo | Placebo Comparator | Patients randomized to the placebo group will receive saline solution for a maximum of 3 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phosphocreatine | Drug | Administration of Phosphocreatine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| days alive and out of hospital at 30 days. | 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. | day 30 or hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | 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. | day 30 |
| Rate of arrhythmia needing treatment |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Landoni, Prof. | Contact | +39022643 | 6151 | landoni.giovanni@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Scientific Institute | Recruiting | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27318357 | Background | 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. | |
| 29409711 | Background | 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. |
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| Placebo |
| Drug |
Saline solution of NaCl 0.9% |
|
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. |
| hospital discharge (which usually occurs in the 30days after randomization) |
| Rate of ICU admissions or criteria for ICU admission | ICU admission | hospital discharge (which usually occurs in the 30days after randomization) |
| Death at 30 days | Death | day 30 |
| Death at 90 days | Death | 90 days |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| D003244 | Consciousness Disorders |
| D012131 | Respiratory Insufficiency |
| D059246 | Tachypnea |
| D007040 | Hypoventilation |
| D013610 | Tachycardia |
| D001919 | Bradycardia |
| D006333 | Heart Failure |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010725 | Phosphocreatine |
| ID | Term |
|---|---|
| D003401 | Creatine |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019606 | Phosphoamino Acids |
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