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

Phase 1

• Conditions: MedDRA version: 23.0Level: PTClassification code 10083659Term: Hypotensive crisisSystem Organ Class: 10047065 - Vascular disorders; Patients with worsening clinical condition requiring MET intervention and in general ward; MedDRA version: 20.1Level: PTClassification code 10045240Term: Type I hypersensitivitySystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2022-003703-16-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-16
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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.
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
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. Previous enrollment and randomization into this trial;
13. Administration of PCr in the previous 30 day.
14. Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>1. cognitive function at 30 days, by the mean of Cognitive Telephone Screening test (COGTEL) (Ihle 2017)<br>2. the rate of arrhythmia needing treatment <br>3. the rate of ICU admissions or criteria for ICU admission<br>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 Outcome Measures

Name	Time	Method
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