Azienda Ospedaliera di Padova
Padua, Italy
Not yet recruiting
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 trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- 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 trial?
9 criteria
- **Tachypnea**: This means breathing very fast.
- **Tachycardia**: This is when the heart beats very fast.
- **Pulse rate < 40 or > 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.
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Verified sites
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Verified Verified Azienda Sanitaria Universitaria Friuli Centrale
Udine, ItalyVerified Azienda Unita Sanitaria Locale Della Romagna
Faenza, Italy
Trial locations
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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.
What is already known about the treatment
Phosphocreatine – Phosphocreatine is administered intravenously and is currently being studied in clinical trials to assess its effectiveness in medical emergency situations. It is primarily investigated for its potential to improve outcomes in patients experiencing critical conditions such as rapid breathing, abnormal heart rates, and sudden changes in consciousness. At the molecular level, phosphocreatine works by providing a quick source of energy to cells, particularly in muscles and the brain, which can help stabilize cellular functions during acute stress. It is classified as a metabolic agent, and its role in energy transfer makes it a promising candidate for supporting patients in emergency care settings.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518474-14-00Protocol codeGR-2021-12375001Estimated enrolment400 patientsSponsorOspedale San Raffaele S.r.l.
sourced from the EU Clinical Trials Register and site verification
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