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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Medipole Hopital Prive Villeurbanne France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Saint Joseph Saint Luc Lyon France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier de Dieppe Dieppe France
Hopital Nord Franche-Comte Belfort France
Centre Hospitalier Chalon-sur-Saône Chalon Sur Saone France
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Iyizjyim dm Cdqcfxbcwnrl Hhvxrgamwan Uaxkzgxfbxstc dq Sehkf Efpbieo (velmqyr Saint Priest En Jarez France
Hniwouhz Uhaahcdwmdeoyi Ssrqnlhedv &otrwus Hkhargp dx Hovllykmmym STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.04.2026

Trial locations

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.

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 ID:
2025-524122-18-00
Protocol code:
69HCL25 0485
Trial Phase:
Therapeutic confirmatory (Phase III)

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