Effect of phosphocreatine, a substance in our body, on patients in inpatient wards

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003703-16-IT

Enrollment

400

Registered

2023-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

Patients with worsening clinical condition requiring MET intervention and in general ward MedDRA version: 20.1 Level: PT Classification code 10045240 Term: Type I hypersensitivity System Organ Class: 10021428 - Immune system disorders MedDRA version: 23.0 Level: PT Classification code 10083659 Term: Hypotensive crisis System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: NEOTON Product Name: NEOTON Product Code: [41/153/91-C/C] Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: FOSFOCREATINA SODICA CAS Number: 922-32-7 Current Spon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1.Threatened airways; 2. Respiratory arrest; 3. Respiratory rate 36 breaths per min; 4. Pulse rate 140 beats per min; 5. Systolic blood pressure 2 points. 8. Written informed consent from the patient him-/herself or the patient's next of kin or the legal representative as requested by the ethics committee. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: Exclusion criteria 1.Age 2 mg/dl; 9. Immediate need for ICU admission; 10. Known allergy to PCr; 11. Previous enrollment and randomization into this trial; 13. Administration of PCr in the previous 30 day. 14. Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the impact of phosphocreatine (PCr) on the number of Days alive and out of hospital at 30 days (DAOH30) in patients reviewed and treated by Medical Emergency Team (MET) in general wards.;Secondary Objective: To assess the impact of phosphocreatine (PCr) on: 1. cognitive function at 30 days, by the mean of Cognitive Telephone Screening test (COGTEL) (Ihle 2017) 2. the rate of arrhythmia needing treatment 3. the rate of ICU admissions or criteria for ICU admission 4. 30-days mortality;Primary end point(s): Number of Days alive and out of hospital;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Main Objective: To assess the impact of phosphocreatine (PCr) on the number of Days alive and out of hospital at 30 days (DAOH30) in patients reviewed and treated by Medical Emergency Team (MET) in general wards.;Secondary Objective: To assess the impact of phosphocreatine (PCr) on: 1. cognitive function at 30 days, by the mean of Cognitive Telephone Screening test (COGTEL) (Ihle 2017) 2. the rate of arrhythmia needing treatment 3. the rate of ICU admissions or criteria for ICU admission 4. 30-days mortality;Primary end point(s): Number of Days alive and out of hospital;Timepoint(s) of evaluation of this end point: 30 days

—

Secondary

Measure	Time frame
Secondary end point(s): Re-hospitalization rate, mortality; number of complications.Cognitive Telephone Screening test (COGTEL);Timepoint(s) of evaluation of this end point: 30 days, 90 days and 1 year	—

Countries

Italy

Contacts

Public ContactAnestesia e Rianimazione

Ospedale San Raffaele

landoni.giovanni@hsr.it0126436152

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026