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The effect of phoSPHocreatine on mEdical emergency team (met) tREated patients: a randomized clinical trial protocol – SPHERE

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518474-14-00
Acronym
GR-2021-12375001
Enrollment
350
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fall in Glasgow Coma Scale of > 2 points, respiratory arrest, bradypnea, tachycardia, sudden fall in level of counciousness, threatened airways, pulse rate < 40 or > 140 bpm, systolic blood pressure < 90 mmHg, tachypnea

Brief summary

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.

Interventions

DRUGNeoton Phlebo 1 g prášek pro infuzní roztok
DRUG9%

Sponsors

Ospedale San Raffaele S.r.l.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026