Study on the Effects of Sodium Lactate and Electrolyte Solution in Comatose Patients After Cardiac Arrest

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients who have experienced a cardiac arrest, which is when the heart suddenly stops beating. After such an event, patients may suffer from post-anoxic brain injury, a type of brain damage that occurs due to a lack of oxygen, and may fall into a coma. The trial aims to evaluate the effectiveness of a treatment using a solution called SODIO LATTATO MONICO, which contains sodium lactate, to help reduce brain injury in patients who are comatose after cardiac arrest.

The study will involve administering the treatment through an intravenous infusion, which means the solution is given directly into a vein. Another solution, Plasmalyte A Viaflo, which contains a mix of electrolytes like magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, and sodium gluconate, may also be used. The purpose of the study is to see if these treatments can help improve outcomes for patients by decreasing the extent of brain injury after a cardiac arrest.

Participants in the study will receive the treatment for a short period, and their progress will be monitored over time. The study will look at various outcomes, such as the level of certain proteins in the blood that indicate brain injury, the patient’s recovery in terms of brain function, and their overall health status during their stay in the hospital. The goal is to gather information that could lead to better treatments for people who have suffered a cardiac arrest and are in a coma.

1 joining the trial

Participation begins after meeting specific criteria: age over 18, a return of spontaneous circulation for at least 20 minutes, a comatose state with a Glasgow coma scale score below 9, and a time to return of spontaneous circulation greater than 15 minutes.

2 initial treatment

The treatment involves the administration of a solution called Plasmalyte A Viaflo and SODIO LATTATO MONICO. These are solutions for infusion given through an intravenous line.

The main objective is to evaluate the effectiveness of hypertonic sodium lactate infusion in reducing brain injury after cardiac arrest in patients who are in a coma.

3 monitoring and assessment

Primary assessment involves measuring neuron-specific enolase levels in the blood 48 hours after the return of spontaneous circulation.

Secondary assessments include evaluating the cerebral performance category score at 90 days, length of stay in the intensive care unit and hospital, mortality rates, vasopressor doses during the first 48 hours, seizure episodes, and peak concentrations of certain proteins in the blood at various intervals.

4 follow-up

The trial will continue until November 30, 2030, with ongoing monitoring of the patient’s condition and any adverse events.

Who Can Join the Study?

Must be older than 18 years.
Must have had a sustained return of spontaneous circulation for at least 20 minutes. This means the heart started beating on its own again after stopping.
Must be in a comatose state, which means being unconscious and not responding to surroundings. This is measured by a score called the Glasgow Coma Scale, and the score must be less than 9.
The time it took to achieve the return of spontaneous circulation must be more than 15 minutes.

Who Cannot Join the Study?

Patients who have a different type of brain injury that is not related to a lack of oxygen.
Patients who are not in a coma.
Patients who have not experienced a cardiac arrest, which is when the heart suddenly stops beating.
Patients who do not have post-cardiac arrest syndrome, a condition that can occur after the heart starts beating again.
Patients who are not within the specified age range for the study.
Patients who are not part of the specific group being studied.
Patients who are not considered part of a vulnerable population, which means they do not have additional health or social factors that make them more at risk.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
CHU Saint Pierre	Brussels	Belgium
CHC MontLegia	Liege	Belgium
Clinique Saint-Pierre Ottignies (CSPO)	Ottignies	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Hypertonic Sodium Lactate is a solution used in this trial to help reduce brain injury in patients who have survived cardiac arrest but are in a coma. The solution is administered through an infusion, which means it is given directly into the bloodstream. The goal of using hypertonic sodium lactate is to see if it can improve recovery by protecting the brain from further damage after the heart has stopped and been restarted.

Investigated diseases:

Post-anoxic brain injury – This condition occurs when the brain is deprived of oxygen for a period of time, leading to damage. The lack of oxygen can cause brain cells to die, resulting in various neurological impairments. Symptoms can vary widely depending on the severity and duration of the oxygen deprivation. Individuals may experience cognitive deficits, motor skill impairments, or changes in behavior. The progression of the injury can be influenced by the initial cause and the duration of the anoxic event. Recovery can be variable, with some individuals regaining function over time, while others may have lasting impairments.

Coma – A coma is a state of prolonged unconsciousness where a person is unresponsive to their environment. It can result from various causes, including traumatic brain injury, stroke, or severe illness. During a coma, the individual does not respond to external stimuli such as sound or pain. The depth and duration of a coma can vary, and it may progress to different levels of consciousness over time. Some individuals may gradually regain awareness, while others may remain in a persistent vegetative state. The underlying cause often influences the progression and potential for recovery.

Cardiac arrest – This is a sudden loss of heart function, leading to a cessation of blood flow to the brain and other vital organs. It is often caused by an electrical disturbance in the heart that disrupts its pumping action. Without immediate medical intervention, cardiac arrest can lead to brain damage or death. The progression of cardiac arrest is rapid, requiring urgent resuscitation efforts to restore circulation. If circulation is restored, the individual may experience complications related to the lack of blood flow during the arrest. The outcome can vary significantly based on the speed and effectiveness of the response.

Post cardiac arrest syndrome – This condition encompasses a range of complications that occur after the return of spontaneous circulation following cardiac arrest. It includes brain injury, myocardial dysfunction, and systemic ischemia/reperfusion response. The syndrome can lead to neurological impairments, heart problems, and systemic inflammatory responses. The progression of symptoms can vary, with some individuals experiencing significant recovery, while others may have lasting deficits. The severity of the initial cardiac arrest and the effectiveness of post-resuscitation care can influence the progression of the syndrome. Recovery and outcomes are highly variable among individuals.

Trial ID:

2023-506031-15-01

Protocol code:

SRB2021260

NCT ID:

NCT05004610

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Sodium Lactate and Electrolyte Solution in Comatose Patients After Cardiac Arrest

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?