The Effect of phoSPHocreatine on mEdical Emergency Team (Met) tREated Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypotension Consciousness, Level Altered Airway Disease Respiratory Failure Tachypnea Bradypnea Tachycardia Bradycardia Cardiac Failure Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Phosphocreatine

Patients randomized to the phosphocreatine group will receive the drug for a maximum of 3 days.

* Patients without renal failure: At the time of randomization (day 0), 4 grams of phosphocreatine will be administered, followed by an additional 4 grams on the same day, with a minimum interval of 20 minutes and a maximum of 4 hours. On day 1 and day 2, after 8 AM, 2 grams of phosphocreatine will be administered twice a day, with a 6-hour interval between doses.
* Patients with history of renal failure: On day 0, patients will receive a single dose of 4 grams of phosphocreatine. On day 1 and day 2, after 8 AM, 2 grams of phosphocreatine will be administered twice a day, with a 6-hour interval between doses.
* Patients with acute kidney injury, without chronic kidney disease: Single dose of 4 grams of phosphocreatine on day 0. No further doses of the drug are planned.

Group Type EXPERIMENTAL

Phosphocreatine

Intervention Type DRUG

Administration of Phosphocreatine

Placebo

Patients randomized to the placebo group will receive saline solution for a maximum of 3 days.

* Patients without renal failure: 200 ml of saline solution twice a day from day 0 to day 2. On day 0, the second bolus should be administered between 20 minutes and 4 hours after the first bolus; on day 1 and day 2, the saline solution should be administered after 8 AM, with the second bolus given 6 hours later.
* Patients with history of renal failure: On day 0, a single infusion of 200 mL of saline solution will be administered. On day 1 and day 2, 200 mL of saline solution will be administered twice a day, after 8 AM, with a 6-hour interval between doses.
* Patients with acute kidney injury, without chronic kidney disease: A single infusion of 200 mL of saline solution on day 0. No further administrations are planned.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline solution of NaCl 0.9%

Interventions

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Phosphocreatine

Administration of Phosphocreatine

Intervention Type DRUG

Placebo

Saline solution of NaCl 0.9%

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No