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Study on the Effect of Phosphocreatine Sodium and Sodium Chloride in Patients Treated by Medical Emergency Teams with Conditions like Rapid Breathing or Low Blood Pressure

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What is this study about?

This clinical trial is focused on patients experiencing serious health conditions that require immediate medical attention, such as tachypnea (rapid breathing), tachycardia (fast heart rate), very low or very high pulse rates, respiratory arrest (stopping of breathing), a significant drop in consciousness, and low blood pressure. The study aims to evaluate the effects of a treatment using phosphocreatine sodium, a substance that may help improve energy supply to cells, compared to a placebo, which is a saline solution. The main goal is to see how these treatments affect the number of days patients are alive and out of the hospital within 30 days.

Participants in the study will receive either the experimental treatment, phosphocreatine sodium, or a placebo through an infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor patients over a period of time to assess their recovery and health status, focusing on how quickly they can return to their normal lives outside the hospital. The trial will help determine if the experimental treatment can provide better outcomes for patients facing these critical health issues.

The study is designed to provide valuable insights into the potential benefits of phosphocreatine sodium for patients in emergency medical situations. By comparing the effects of the treatment with a placebo, researchers aim to understand its impact on patient recovery and hospital discharge rates. This information could lead to improved treatment options for individuals experiencing severe medical emergencies.

1 joining the study

Upon joining the study, the patient must be admitted to the hospital but not in the intensive care unit (ICU).

The patient must be at least 18 years old and provide written informed consent, either personally or through a legal representative.

2 eligibility assessment

The patient will be assessed for specific medical conditions such as tachypnea (rapid breathing), tachycardia (rapid heart rate), or a significant drop in consciousness level.

The patient must have a serum creatinine level of 2 mg/dl or less and may have conditions like impending cardiac failure or cardiac arrest.

3 randomization

The patient will be randomly assigned to one of two groups: the experimental group receiving phosphocreatine or the control group receiving a saline solution.

4 treatment administration

The treatment involves an infusion of either phosphocreatine sodium or sodium chloride, both administered as a solution for infusion.

The specific dosage and frequency will be determined by the study protocol.

5 monitoring and follow-up

The patient’s health will be monitored to assess the number of days they are alive and out of the hospital within 30 days after randomization.

The primary endpoint is to evaluate the days alive and out-of-hospital at day 30 (DAOH30).

6 study completion

The study is estimated to end on May 31, 2027, with recruitment starting on October 8, 2024.

The patient’s participation will contribute to understanding the effects of phosphocreatine on patients treated by the medical emergency team.

Who Can Join the Study?

  • The patient must be admitted to the hospital, but not in the Intensive Care Unit (ICU).
  • The patient must be 18 years old or older.
  • The patient or their legal representative must provide written informed consent, which means they agree to participate after understanding the study.
  • The patient’s blood test must show a serum creatinine level of 2 mg/dl or less. Serum creatinine is a measure of kidney function.
  • The patient must have a risk of or existing heart problems, such as heart failure or cardiac arrest, and the Medical Emergency Team (MET) must be called for at least one of the following reasons:
    • Threatened airways, meaning there is a risk of breathing problems.
    • Respiratory arrest, which is when breathing stops.
    • Breathing rate is less than 5 or more than 36 breaths per minute.
    • Heart rate is less than 40 or more than 140 beats per minute.
    • Systolic blood pressure is less than 90 mm Hg. Systolic blood pressure is the top number in a blood pressure reading, indicating the pressure in the arteries when the heart beats.
    • Sudden decrease in the level of consciousness, meaning the patient becomes less alert or aware.
    • A drop of more than 2 points in the Glasgow Coma Scale, which is a scale used to measure a person’s level of consciousness.

Who Cannot Join the Study?

  • Tachypnea: This means breathing very fast.
  • Tachycardia: This is when the heart beats very fast.
  • Pulse rate 140 bpm: If your heart rate is less than 40 beats per minute or more than 140 beats per minute.
  • Respiratory arrest: This is when breathing stops.
  • Fall in Glasgow Coma Scale of > 2 points: The Glasgow Coma Scale is a way to measure how awake and aware someone is. A drop of more than 2 points means a significant decrease in alertness.
  • Threatened airways: This means there is a risk of not being able to breathe properly.
  • Systolic blood pressure < 90 mmHg: If the top number of your blood pressure is less than 90, which is considered low.
  • Bradypnea: This means breathing very slowly.
  • Sudden fall in level of consciousness: This is when someone suddenly becomes much less aware or awake.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Ospedale Cardinal Massaia Asti Italy
Azienda Ospedaliera di Padova Padua Italy
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Di Pisa Pisa Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Universita Degli Studi Di Brescia Brescia Italy
Aohjvch Ouolgysvoip Rggcbpgvy Sin Ctbmc Potenza Italy
Atuwwos Onynenfetemedpyvkncjxzsmr Da Cetlezu Cosenza Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
08.10.2024

Trial locations

Investigated drugs:

Phosphocreatine (PCr) is being tested in this clinical trial to see if it can help patients treated by medical emergency teams. The goal is to find out if phosphocreatine can increase the number of days patients are alive and out of the hospital within 30 days after treatment.

Tachypnea – Tachypnea is a condition characterized by an abnormally rapid breathing rate. It often occurs as a response to the body’s need for more oxygen or to expel carbon dioxide more quickly. This condition can be seen in various situations, such as exercise, fever, or respiratory illnesses. The increased breathing rate can lead to a feeling of breathlessness or shortness of breath. It is important to monitor the underlying cause to prevent further complications.

Tachycardia – Tachycardia refers to a condition where the heart beats faster than normal while at rest. This rapid heart rate can be due to various factors, including stress, anxiety, or underlying heart conditions. It may cause symptoms like palpitations, dizziness, or chest discomfort. The heart’s increased workload can affect its efficiency in pumping blood. Understanding the cause is crucial for managing the condition effectively.

Respiratory Arrest – Respiratory arrest is a serious condition where breathing stops completely. This can result from various causes, such as airway obstruction, severe asthma, or neurological issues. Without intervention, it can lead to a lack of oxygen in the body, affecting vital organs. Immediate medical attention is necessary to restore breathing and prevent damage. The focus is on identifying and addressing the underlying cause.

Bradypnea – Bradypnea is characterized by an abnormally slow breathing rate. It can occur due to factors like drug use, metabolic disorders, or neurological conditions. The reduced breathing rate can lead to insufficient oxygen intake and carbon dioxide buildup. Symptoms may include fatigue, dizziness, or confusion. Monitoring and addressing the underlying cause is essential for managing this condition.

Sudden Fall in Level of Consciousness – A sudden fall in the level of consciousness involves an abrupt change in awareness or alertness. This can be caused by various factors, including head injury, stroke, or metabolic imbalances. The individual may experience confusion, drowsiness, or even loss of consciousness. It is crucial to identify the cause quickly to prevent further complications. Immediate medical evaluation is often required to determine the underlying issue.

Trial ID:
2024-518474-14-00
Protocol code:
GR-2021-12375001
NCT ID:
NCT06503016
Trial Phase:
Therapeutic confirmatory (Phase III)

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