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Study of dexmedetomidine and a drug combination for treating patients on mechanical ventilation with septic shock.

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients suffering from Septic Shock, a life-threatening condition where a severe infection leads to dangerously low blood pressure and organ failure. Specifically, the research looks at individuals with refractory septic shock, which means the condition is not responding well to standard treatments. The purpose of the study is to evaluate if the drug dexmedetomidine can help when used alongside regular medical care for patients who are receiving mechanical ventilation, a method of using a machine to help a patient breathe.

In addition to the main drug being studied, patients may receive other medications as part of their standard care. These include midazolam, dobutamine hydrochloride, hydrocortisone acetate, lidocaine hydrochloride monohydrate, propofol, and norepinephrine. These medications are administered through an intravenous injection, which is a way of delivering liquids directly into a vein. The study will involve comparing the effects of adding dexmedetomidine to the usual treatment versus continuing with the standard care alone.

During the course of the study, health professionals will monitor various aspects of the patient's condition. This includes tracking mean arterial pressure, which is the average pressure in the arteries during a single cardiac cycle, and checking for atrial fibrillation, a common irregular heart rhythm. The study also observes the use of vasopressors, which are drugs used to raise blood pressure, and monitors for bradycardia, a condition where the heart rate is slower than normal. Other observations include checking for delirium, a state of confusion, and measuring lactate levels in the blood to assess how well the body is functioning.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>participation</b> in the study

    Upon joining the study, dexmedetomidine is administered via intravenous injection (medicine delivered through a vein). the dose is 23.4 microgrammes per kilogram of body weight.

    Standard care is also provided, which includes several medications delivered through intravenous injection: midazolam at 0.3 milligrams per kilogram, hydrocortisone at 200 milligrams, propofol at 2 milligrams per kilogram, and norepinephrine at 7.2 milligrams per kilogram.

  2. Step 2

    <b>monitoring</b> and <b>assessments</b>

    During the first 24 hours, several measurements are taken, including blood pressure, lactate levels (a substance in the blood), and the amount of vasopressors (medicines used to raise blood pressure) required.

    blood samples are collected at specific times: at the start, at 12 hours, at 24 hours, at 48 hours, and on day 5 to check electrolytes (minerals like sodium, potassium, and chloride) and other substances in the blood.

    urine samples are collected at 24 hours to check for electrolytes and other substances.

  3. Step 3

    <b>ongoing follow-up</b>

    Over the next 30 days, your vital status (whether you are alive) is monitored. this includes checking at 72 hours, at the time of intensive care unit discharge, and at 30 days.

    Daily checks are performed to screen for delirium (a state of confusion) and to monitor heart rhythm issues, such as atrial fibrillation (an irregular heartbeat).

    The amount of fluid intake and fluid loss is recorded over the first 6 days.

    Additional follow-up regarding vital status is conducted at 90 days.

Who can join the trial?

11 criteria

  • You must be at least 18 years old.
  • You must have septic shock, which is a life-threatening condition caused by a severe infection that leads to a dangerous drop in blood pressure and organ dysfunction.
  • Your blood pressure must remain low even when receiving vasopressors, which are medications used to tighten blood vessels and increase blood pressure.
  • Your MAP (Mean Arterial Pressure), which is the average blood pressure in your arteries during one cardiac cycle, must be maintained above 65 mmHg using medication.
  • Your serum lactate level, a marker in the blood that indicates how well your tissues are receiving oxygen, must be higher than 2 mmol/L even after receiving fluids.
  • You must show catecholamine resistance, meaning you require a high dose of medication (specifically norepinephrine) to maintain blood pressure for more than two hours, and you show signs of circulatory failure, such as high lactate, skin discoloration called mottling, or oliguria (producing very little urine).
  • You must have received adequate fluid resuscitation, which means you have been given a specific large amount of fluids through an IV to help stabilize your blood pressure.
  • You must be receiving invasive mechanical ventilation, which means a machine is helping you breathe through a tube placed in your airway.
  • You must be covered by a social security scheme or a similar health insurance plan.
  • Written consent must be provided by you, or by a trusted person, family member, or relative if you are unable to sign it yourself.
  • In certain emergency situations where a representative is not immediately available, the study may proceed under emergency inclusion rules to ensure treatment is not delayed, provided that consent is obtained from a relative as soon as they arrive.

Who cannot join the trial?

16 criteria

  • A low cardiac index, which is a measure of how much blood your heart pumps relative to your body size, after fluids have been given.
  • Patients for whom a decision has been made to stop or limit life-sustaining treatments, such as machines or medicines that keep the body functioning.
  • Patients who are under legal protection, such as having a court-appointed guardian or curator.
  • Patients who cannot take the specific medications used in this study, which include norepinephrine (a medicine to raise blood pressure), midazolam (a sedative), propofol (a sedative), or hydrocortisone (a steroid).
  • Patients who are currently taking part in another medical study that prevents them from joining this one.
  • Pregnant women (confirmed by a blood test for the pregnancy hormone β-HCG) or women who are currently breastfeeding.
  • A heart rate that is too slow, known as bradycardia (less than 55 beats per minute), unless the patient is taking β-blockers (a type of heart medicine).
  • Patients with a specific heart rhythm problem called second- or third-degree AV block, which is a delay or blockage in the electrical signals of the heart, unless they have a pacemaker.
  • Patients who are very close to death or whose death appears to be expected within 24 hours based on a doctor's assessment.
  • Acute hepatocellular failure, which is sudden and severe liver failure, combined with low levels of PT (a blood clotting test) and Factor V (a protein that helps blood clot), unless the patient has DIC (a condition where blood clots form throughout the body).
  • Patients with an allergy or hypersensitivity to dexmedetomidine or any of its inactive ingredients.
  • Patients with advanced heart block (grade 2 or 3) who do not have a pacemaker.
  • Patients with uncontrolled hypotension, which means blood pressure that remains dangerously low.
  • Patients with acute cerebrovascular conditions, which are sudden problems related to blood flow in the brain, such as a stroke.
  • Patients who have already received dexmedetomidine before being officially assigned to the study groups.
  • Patients who have taken iproniazid (a type of medication) within the 15 days before being assigned to the study groups.
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Investigated drugs

  • Dexmedetomidine

    is a medication being tested in this study to see if it helps calm the body's nervous system response in patients suffering from severe, life-threatening infections (septic shock).

  • Dobutamine

    is used as a background therapy to help strengthen the heart's pumping action and improve blood flow.

  • Hydrocortisone

    is a type of steroid used to reduce inflammation and help the body respond better to medical treatment during severe illness.

  • Lidocaine

    is included in the background treatment, which can sometimes be used to help manage pain or stabilize certain bodily functions.

  • Propofol

    is a medication used to induce and maintain sedation, helping patients remain asleep and comfortable while they are on a breathing machine.

  • Norepinephrine

    is a medication used to raise blood pressure in patients whose blood pressure has dropped to dangerously low levels due to shock.

What is already known about the treatment

  • Dexmedetomidine

    This medication is an intravenous solution used to provide sedation and calm patients during medical procedures. It is widely recognized in medical practice for helping to manage agitation and sedation in intensive care settings. It works by selectively binding to specific receptors in the brain called alpha-2 adrenergic receptors, which helps decrease nervous system activity. It is classified as a sedative and an alpha-2 adrenergic agonist.

  • Dobutamine hydrochloride

    This medicine is administered through an intravenous injection and is commonly used to treat certain types of heart failure. It is a well-established treatment used to help the heart pump blood more effectively during medical emergencies. At a molecular level, it stimulates specific receptors on the heart cells to increase the force and rate of contractions. It is classified as an inotropic agent used to support heart function.

  • Hydrocortisone acetate

    This substance is given via intravenous injection to reduce inflammation and manage stress in the body. It is a standard treatment used to address severe allergic reactions, inflammatory conditions, and certain hormone deficiencies. The medication works by mimicking the effects of natural cortisol, which helps to suppress the immune system's inflammatory response. It is classified as a corticosteroid.

  • Lidocaine hydrochloride monohydrate

    This medication is administered as an intravenous injection and is used to treat irregular heart rhythms and to provide pain relief. It is a common drug in clinical settings used to stabilize the electrical activity of the heart. It works by blocking sodium channels in nerve and muscle cells, which stops the movement of electrical signals that cause pain or irregular beats. It is classified as a local anesthetic and antiarrhythmic agent.

  • Propofol

    This is an intravenous medication used to induce and maintain sedation or anesthesia for patients. It is one of the most frequently used drugs in hospitals to help patients sleep during medical procedures or while on breathing machines. It works by enhancing the activity of a calming chemical in the brain called GABA, which leads to rapid sleepiness. It is classified as a short-acting intravenous anesthetic.

  • Noradrenaline tartrate

    This medication is administered through an intravenous injection and is used to treat dangerously low blood pressure. It is a critical drug used in emergency situations, such as septic shock, to help stabilize a patient's circulation. It works by stimulating receptors on the walls of blood vessels, causing them to tighten and increase blood pressure. It is classified as a vasopressor.

Investigated diseases

Septic shock - This is a severe condition that occurs when an infection triggers a widespread inflammatory response throughout the body. As the condition progresses, it leads to dangerously low blood pressure and inadequate blood flow to vital organs. This lack of blood supply can cause organs like the kidneys, heart, and lungs to malfunction. The process often involves a rapid decline in the body's ability to maintain stable circulation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524122-18-00Protocol code69HCL25 0485Estimated enrolment360 patientsSponsorHospices Civils De Lyon

sourced from the EU Clinical Trials Register and site verification

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