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Study on Erythromycin Lactobionate for Improving Gastric Emptying in Stroke Patients Needing Mechanical Thrombectomy

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients who have experienced an ischemic stroke, a condition where blood flow to the brain is blocked, often requiring urgent medical procedures. The study investigates the use of erythromycin lactobionate, a medication administered through an intravenous infusion, to help manage the stomach contents of these patients. Specifically, the trial aims to see if this medication can reduce the size of the stomach area, as measured by an ultrasound, before patients undergo a procedure called mechanical thrombectomy, which is used to remove the blood clot causing the stroke.

The purpose of the study is to evaluate how effective erythromycin lactobionate is in decreasing the stomach's antral surface area, which is the part of the stomach closest to the small intestine. This is important because having a full stomach can complicate medical procedures. Patients who are found to have significant stomach contents, as determined by an ultrasound scan, will be included in the study. The trial will monitor changes in the stomach area before and after the thrombectomy procedure to assess the medication's impact.

Throughout the study, various observations will be made, such as the frequency of patients with reduced stomach size and any changes in medical management strategies due to the ultrasound findings. The trial will also track any complications that may arise during the thrombectomy procedure, such as low blood pressure or breathing difficulties, and any side effects related to the administration of erythromycin lactobionate. The study is designed to provide valuable insights into the potential benefits of using this medication in stroke patients undergoing emergency procedures.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after experiencing an ischemic stroke and requiring emergency neuroradiology for a procedure called mechanical thrombectomy.
Eligibility is confirmed if the stomach is full, as shown by an ultrasound measurement of the antral area greater than 340 mm².
Informed consent is obtained from the patient or a relative.
Step 2
Initial assessment
An ultrasound of the stomach is performed to measure the antral area.
This measurement helps determine the initial state of the stomach before the procedure.
Step 3
Medication administration
The medication erythromycin lactobionate is administered through an intravenous infusion.
This medication is used to help reduce the antral surface area during the procedure.
Step 4
Mechanical thrombectomy procedure
The mechanical thrombectomy procedure is performed in the neuroradiology unit.
The procedure aims to remove the blockage in the blood vessel caused by the stroke.
Step 5
Post-procedure assessment
A second ultrasound of the stomach is conducted to measure the antral area after the procedure.
The primary goal is to evaluate the reduction in the antral surface area compared to the initial measurement.
Step 6
Monitoring and follow-up
The frequency and proportion of patients with a significant reduction in antral surface area are recorded.
Any complications during the procedure, such as low blood pressure or breathing difficulties, are monitored.
The use of oxygen therapy and the need for intensive care post-procedure are evaluated.

Who can join the trial?

6 criteria

Patients must have had an ischemic stroke, which is a type of stroke caused by a blockage in a blood vessel in the brain.
Patients need to require emergency treatment called interventional neuroradiology for a procedure known as mechanical thrombectomy. This is a method used to remove the blockage from the blood vessel.
Patients or their relatives must provide informed consent, which means they agree to participate in the study after understanding what it involves. In emergencies, consent can be obtained through a special procedure.
Patients must be part of a health insurance plan.
Both male and female patients can participate.
Patients must be adults, as the study is for major patients.

Who cannot join the trial?

5 criteria

Patients who do not have a full stomach as shown by an ultrasound measurement taken before the procedure.
Patients who are not experiencing an ischemic stroke, which is a type of stroke caused by a blockage in the blood vessels supplying the brain.
Patients who do not require interventional neuroradiology, which is a special procedure to treat the stroke.
Patients who are not in the age range specified for the study.
Patients who are part of a vulnerable population, meaning they might need special protection or care.

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Investigated drugs

Erythromycin is an antibiotic that is being studied for its potential to help with gastric emptying in stroke patients. In this trial, it is used to see if it can reduce the size of the stomach's antral area, which is important for patients who need an emergency procedure called mechanical thrombectomy. This procedure is used to treat ischemic stroke, a condition where a blood clot blocks blood flow to the brain.

Erythromycin Lactobionate

What is already known about the treatment

Erythromycin – Erythromycin is administered intravenously, often used in emergency settings. It is currently being studied for its effects on gastric emptying in stroke patients who require mechanical thrombectomy. The main therapeutic indication in this context is to reduce the antral surface area in the stomach, which can be beneficial during emergency procedures. At the molecular level, erythromycin works by stimulating motilin receptors in the gastrointestinal tract, enhancing gastric motility. It is classified as a macrolide antibiotic, although in this trial, its prokinetic properties are being explored.

Investigated diseases

Ischemic Stroke – Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes, leading to potential loss of brain function. Symptoms often include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression of an ischemic stroke can vary, with some individuals experiencing rapid onset of severe symptoms, while others may have a more gradual development. Immediate medical intervention is crucial to minimize brain damage and improve outcomes.