The effect of phoSPHocreatine on mEdical emergency team (met) tREated patients: a randomized clinical trial protocol – SPHERE
Phase 3 – large-scale trial before approval
Conditions:
respiratory arrest
threatened airways
tachycardia
bradypnea
pulse rate < 40 or > 140 bpm
sudden fall in level of counciousness
tachypnea
systolic blood pressure < 90 mmHg
fall in Glasgow Coma Scale of > 2 points
Sponsor: Ospedale San Raffaele S.r.l.
trial.available_in:
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Overview
Trial status: Authorised
How to calculate DAH30 (days alive and out-of-hospital at day 30): Has patient died in hospital or after discharge on any day within the first 30-days after randomization? If YES we will give 0 points Is the patient discharged from hospital on Day 5 after randomization but is subsequently readmitted for 5-days before their second hospital discharge? If YES we will give 20 points Is patient in a post- discharge nursing facility? If YES: we won’t consider as days at home.
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 350 participants
Interventions
Neoton Phlebo 1 g prášek pro infuzní roztok
Drug
Sodio cloruro Fresenius Kabi Italia 0,9%, soluzione per infusione
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