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A Study of Intravenous Lidocaine to Reduce Inflammation in Patients Undergoing Heart Valve or Coronary Artery Bypass Surgery with Heart-Lung Machine

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What is this trial about?

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

This study involves patients who are having planned heart surgery to repair or replace heart valves or to bypass blocked coronary arteries. During these operations, a heart-lung machine, also called cardiopulmonary bypass, is used to temporarily take over the work of the heart and lungs. This machine can trigger a body-wide inflammatory response, which is the body's reaction to injury or stress, and this response can sometimes lead to problems after surgery such as kidney injury, infection, organ dysfunction, bleeding, low blood pressure, breathing difficulties, and brain-related issues. The study will test whether giving lidocaine through a vein during and after surgery can reduce this inflammatory response. Lidocaine is a medication commonly used as a local painkiller, but it may also have effects that calm down inflammation in the body. Patients will receive either lidocaine or placebo, which is a solution that looks the same but contains only sodium chloride, a salt water solution.

The purpose of the study is to find out whether lidocaine given through a vein can lower the levels of a substance called interleukin-6 in the blood six hours after surgery ends. Interleukin-6 is a marker of inflammation in the body, and high levels of it are associated with the inflammatory response caused by the heart-lung machine. The study will also measure other markers of inflammation and heart stress, including C-reactive protein, high-sensitivity Troponin T, and TNF-α, at different times before, during, and after surgery. Additionally, the study will look at whether patients who receive lidocaine have fewer complications after surgery, spend less time in the intensive care unit, have better survival rates one month after surgery, and experience less pain in the days following the operation.

Patients in the study will be randomly assigned to receive either lidocaine or placebo during their surgery and for a period afterward. Neither the patients nor the doctors will know which treatment is being given, which helps ensure fair and accurate results. Blood samples will be taken at specific times to measure the inflammation markers, and information about any complications, length of stay in the intensive care unit, heart rhythm problems after the heart is restarted, pain levels, and need for pain medication will be collected. The study is expected to begin enrolling patients in October 2025 and continue until April 2027.

The research process

The trial runs in 11 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Informed consent and study entry

    After receiving adequate information about the study, you will provide your informed consent to participate.

    This step occurs before your scheduled heart valve or coronary artery surgery.

  2. Step 2

    Pre-anesthesia blood sample collection

    Before anesthesia is administered, a blood sample will be taken from an artery.

    This sample will be used to measure baseline levels of certain substances in your blood, including C-reactive protein (a marker of inflammation), high-sensitivity Troponin T (a marker of heart muscle damage), and TNF-α (another inflammation marker).

  3. Step 3

    Start of cardiopulmonary bypass and blood sample collection

    Your surgery will proceed as planned, using a cardiopulmonary bypass machine. This machine temporarily takes over the function of your heart and lungs during the operation.

    At the start of the cardiopulmonary bypass, another blood sample will be taken from an artery to measure the same substances as before.

  4. Step 4

    Administration of study medication

    During your surgery, you will receive either lidocaine hydrochloride or sodium chloride (saline solution) through an intravenous infusion. Lidocaine is a medication that may help reduce inflammation.

    The medication will be administered directly into a vein. The specific dosage and duration of administration will be determined by the study protocol.

    This is a double-blind study, which means neither you nor your medical team will know which medication you are receiving during the trial.

  5. Step 5

    End of surgery blood sample collection

    At the end of your surgery, another arterial blood sample will be collected.

    This sample will again measure levels of C-reactive protein, high-sensitivity Troponin T, and TNF-α.

  6. Step 6

    Six hours after surgery blood sample collection

    Six hours after your surgery is completed, an arterial blood sample will be taken.

    This sample will measure levels of Interleukin-6 (a key marker of inflammation in the body), as well as C-reactive protein, high-sensitivity Troponin T, and TNF-α.

    The Interleukin-6 level at this time point is the main measure being evaluated in this study.

  7. Step 7

    Twenty-four hours after surgery blood sample collection

    Twenty-four hours after your surgery, a final arterial blood sample will be collected.

    This sample will measure the same substances: C-reactive protein, high-sensitivity Troponin T, and TNF-α.

  8. Step 8

    Monitoring during intensive care unit stay

    During your stay in the Intensive Care Unit, you will be monitored for any complications related to inflammation after surgery.

    These may include kidney problems, infections, organ dysfunction, bleeding requiring transfusion, low blood pressure requiring medication, breathing difficulties, and neurological issues.

    The total length of your stay in the Intensive Care Unit will be recorded.

  9. Step 9

    Postoperative pain and medication monitoring

    During the first 48 hours after surgery, any pain you experience will be monitored.

    The number of times you require additional pain medication beyond the regular schedule will be recorded.

    The total amount of opioid pain medication you receive will be calculated and converted to an equivalent dose of intravenous morphine for comparison purposes.

  10. Step 10

    Assessment of heart rhythm after surgery

    After the clamp on your aorta (the main artery from your heart) is removed during surgery, your medical team will observe whether you experience ventricular fibrillation, which is an abnormal heart rhythm.

    If this occurs, they will record whether electrical defibrillation (a controlled electric shock to restore normal heart rhythm) is needed.

  11. Step 11

    One-month follow-up

    Your status will be assessed 30 days after your surgery date.

    This assessment will determine whether you have experienced any fatal complications within the first month following your operation.

Who can join the trial?

5 criteria

  • You must be older than 18 years of age
  • Your surgery must be scheduled in advance, meaning it is a planned surgery and not an emergency
  • You must be having surgery on your heart valves (the parts of your heart that control blood flow) or coronary arteries (the blood vessels that supply blood to your heart muscle), which may include repair or replacement of these structures
  • Your surgery must use a cardiopulmonary bypass, which is a machine that temporarily takes over the work of your heart and lungs during the operation
  • You must be able to understand the information about the study and agree to participate by signing an informed consent form, which is a document showing you understand and accept to take part in the study

Who cannot join the trial?

9 criteria

  • Emergency surgery - if you need heart surgery right away and it cannot be planned in advance, you cannot join this study
  • Allergy to lidocaine - if you have ever had an allergic reaction to lidocaine (a medication used to numb areas or control heart rhythm), you cannot participate
  • Severe liver problems - if your liver is not working properly, you cannot join because your body may not process the study medication safely
  • Severe kidney problems - if your kidneys are not working well enough, you cannot participate in this study
  • Heart rhythm problems - if you have certain abnormal heart rhythms or heart block (when electrical signals in your heart are delayed or blocked), you cannot join
  • Seizure disorder - if you have epilepsy or a history of seizures (sudden uncontrolled electrical activity in the brain), you cannot participate
  • Pregnancy or breastfeeding - if you are pregnant, might be pregnant, or are breastfeeding, you cannot join this study
  • Other ongoing studies - if you are currently taking part in another medical research study, you may not be able to participate
  • Unable to give consent - if you cannot understand and agree to participate in the study on your own, you cannot join
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Investigated drugs

  • Lidocaine

    is a medication that will be given through a vein (intravenously) during the study. It is commonly used as a local anesthetic to numb areas of the body, but in this trial it is being tested to see if it can help reduce inflammation in the body that happens during heart surgery when a heart-lung machine is used. The researchers want to find out if this medication can lower certain inflammatory markers in the blood after surgery.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active medicine. Some patients will receive this instead of lidocaine so that researchers can compare the results and determine if lidocaine actually has an effect on reducing inflammation during heart surgery.

What is already known about the treatment

Lidocaine – Lidocaine is a medication that can be given through an intravenous injection directly into the bloodstream. In this clinical trial, it is being studied for its potential ability to reduce inflammatory responses in patients undergoing heart surgery with cardiopulmonary bypass, which is a machine that temporarily takes over the function of the heart and lungs during surgery. The medication works at the molecular level by blocking sodium channels in cells, which may help decrease the production of inflammatory substances like interleukin-6 that can cause complications after surgery. Lidocaine belongs to a class of drugs called local anesthetics and antiarrhythmic agents, commonly used to numb areas during medical procedures and to treat irregular heartbeats.

Investigated diseases

  • Systemic Inflammatory Response Syndrome

    Systemic inflammatory response syndrome is a widespread inflammatory reaction of the body that can occur after major surgical procedures, particularly those involving cardiopulmonary bypass during heart surgery. The condition develops when the immune system releases inflammatory substances throughout the bloodstream in response to surgical trauma or other triggers. This response involves the release of various inflammatory markers, including interleukin-6, C-reactive protein, and tumor necrosis factor alpha. The syndrome can affect multiple organ systems as inflammation spreads through the body. Patients may experience increased body temperature, elevated heart rate, and changes in white blood cell counts. The condition can lead to various complications affecting the kidneys, lungs, heart, and other organs if the inflammatory response becomes excessive.

  • Acute Kidney Injury

    Acute kidney injury is a sudden decline in kidney function that can occur as a complication following cardiac surgery. The condition develops when the kidneys lose their ability to filter waste products from the blood effectively. This dysfunction may result from reduced blood flow to the kidneys, inflammatory processes, or direct injury during surgical procedures. Patients experience a buildup of waste products in the blood and may have changes in urine output. The severity can range from mild dysfunction to complete loss of kidney filtering ability. The condition typically develops within hours to days after the triggering event.

  • Sepsis

    Sepsis is a serious condition that occurs when the body's response to an infection causes widespread inflammation throughout the body. The condition can develop after surgery if bacteria or other infectious agents enter the bloodstream or tissues. The immune system releases chemicals to fight the infection, but these substances can trigger inflammatory changes that affect multiple organ systems. Patients may experience fever, rapid heart rate, rapid breathing, and confusion. The condition represents a dysregulated immune response where the body's defense mechanisms cause harm to its own tissues. Sepsis can progress rapidly and affect blood pressure, organ function, and tissue perfusion.

  • Multiple Organ Dysfunction Syndrome

    Multiple organ dysfunction syndrome is a condition where two or more organ systems fail to function properly simultaneously. This syndrome can develop as a consequence of severe systemic inflammation, inadequate blood flow, or other complications following major surgery. The condition typically progresses over time as one failing organ system places additional stress on others. Affected organs may include the lungs, kidneys, liver, heart, and brain. Each organ's dysfunction contributes to the overall deterioration of the patient's condition. The syndrome represents a cascade of physiological failures where the body's systems can no longer maintain normal function.

  • Vasoplegia

    Vasoplegia is a condition characterized by severe dilation of blood vessels leading to abnormally low blood pressure despite adequate fluid volume in the circulatory system. The condition commonly occurs after cardiac surgery involving cardiopulmonary bypass due to inflammatory responses. Blood vessels lose their normal tone and ability to constrict properly, causing blood pressure to drop. The heart may pump adequately, but the dilated vessels cannot maintain sufficient pressure for proper blood flow to organs. Patients require medications to help constrict blood vessels and restore normal blood pressure. The condition results from complex inflammatory and metabolic changes affecting the vessel walls.

  • Ventricular Fibrillation

    Ventricular fibrillation is a severe abnormal heart rhythm where the lower chambers of the heart quiver rapidly and chaotically instead of beating effectively. During this arrhythmia, the heart cannot pump blood to the body because the muscle fibers contract in an uncoordinated manner. The condition can occur spontaneously during cardiac surgery, particularly when blood flow is restored to the heart after aortic clamping. The electrical signals in the heart become disorganized, causing the ventricles to flutter at very high rates. Without coordinated contractions, the heart cannot maintain circulation. The rhythm must be corrected quickly to restore normal heart function and blood flow.

Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523534-11-00Estimated enrolment90 patientsSponsorHospital San Pedro

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