Hypotension, Consciousness, Level Altered, Airway Disease, Respiratory Failure, Tachypnea, Bradypnea, Tachycardia, Bradycardia, Cardiac Failure, Cardiac Arrest
Conditions
Brief 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.
Interventions
DRUGPhosphocreatine
Administration of Phosphocreatine
DRUGPlacebo
Saline solution of NaCl 0.9%
Sponsors
Silvia Ajello
Università Vita-Salute San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Admitted in hospital (but outside ICU) 2. Age\>=18 years 3. Written informed consent 4. Serum creatinine \<=2 mg/dl 5. 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: 1. Threatened airways; 2. Respiratory arrest; 3. Respiratory rate \<5 or \>36 breaths per min; 4. Pulse rate \<40 or \>140 beats per min; 5. Systolic blood pressure \< 90 mm Hg; 6. Sudden fall in level of consciousness; 7. Fall in Glasgow coma scale of \> 2 points.
Exclusion criteria
1. Age \< 18 years; 2. Ongoing cardiac massage; 3. Current hospital admission from a care nursing facility; 4. Planned discharge to a care nursing facility; 5. Reasons for withdrawal of life-sustaining therapy; 6. History of kidney transplantation; 7. Solitary kidney (by any reason); 8. Serum Creatinine \> 2 mg/dl; 9. Immediate need for ICU admission; 10. Known allergy to PCr; 11. Pregnancy; 12. Previous enrollment and randomization into this trial; 13. Administration of PCr in the previous 30 day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| days alive and out of hospital at 30 days. | 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
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | 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. |
| Rate of arrhythmia needing treatment | 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. |
| Rate of ICU admissions or criteria for ICU admission | hospital discharge (which usually occurs in the 30days after randomization) | ICU admission |
| Death at 30 days | day 30 | Death |
| Death at 90 days | 90 days | Death |
Countries
Italy
Contacts
Primary ContactGiovanni Landoni, Prof.
Outcome results
None listed