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Study on Reduction of Toxicant Levels in Blood through Combined Digestive Decontamination with Activated Charcoal and Intestinal Purge for Intubated Patients with Major Poisoning in Intensive Care

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 involves patients who have been intoxicated by functional toxicants (substances that affect bodily functions, such as psychotropic or cardiotropic drugs) and are receiving care in an intensive care unit while on a breathing machine (intubated). The purpose is to determine if using a combination of activated charcoal (a substance that can bind to toxins in the digestive system) plus an intestinal purge (a method to clear the intestines) is more effective at reducing the amount of toxic substances in the blood compared to standard care.

The study will measure how much the level of toxic substances in the blood decreases over time (at 24, 48, 72, and 96 hours) after treatment begins. Researchers will also track how many days patients survive without needing mechanical breathing support or intensive care, as well as any side effects that might occur such as vomiting, pneumonia, abdominal pain, diarrhea, or allergic reactions.

The research process

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

  1. Step 1

    Admission to Intensive Care

    After joining the DIMREATOX study, you will be admitted to intensive care for treatment of poisoning by a functional toxicant (such as psychotropic or cardiotropic drugs).

    You will be intubated (have a breathing tube inserted) and have a nasogastric tube placed through your nose into your stomach.

  2. Step 2

    Randomization

    You will be randomly assigned to one of two groups: either the intervention group receiving combined digestive decontamination treatment or the control group receiving standard care.

    Blood samples will be taken at this point to measure the initial concentration of toxicants in your blood.

  3. Step 3

    Treatment (Intervention Group)

    If you are in the intervention group, you will receive two types of treatments through your nasogastric tube:

    Activated charcoal (TOXICARB suspension) which helps absorb toxic substances in your digestive system.

    Intestinal purge (FORTRANS powder mixed with water) containing sodium hydrogen carbonate, potassium chloride, sodium chloride, sodium sulfate anhydrous, and macrogol 4000 to help remove toxins from your intestines.

  4. Step 4

    Blood Sampling

    Blood samples will be collected at specific intervals to monitor toxicant levels in your blood.

    Samples will be taken at 24 hours, 48 hours, 72 hours, and 96 hours after randomization to measure changes in toxicant concentration.

  5. Step 5

    Monitoring Side Effects

    During your participation, medical staff will monitor you for side effects including:

    Episodes of vomiting, upper abdominal pain, or diarrhea

    Development of ventilator-associated pneumonia (lung infection related to being on a breathing machine)

    Hypersensitivity reactions such as allergic shock, swelling, hives, rash, or itching

  6. Step 6

    Recovery Monitoring

    Your recovery will be tracked for 28 days after randomization.

    The medical team will record the number of days you are alive without needing mechanical ventilation (breathing machine) and days alive without needing intensive care.

Who can join the trial?

7 criteria

  • You must be at least 18 years old
  • You must be suffering from drug poisoning/overdose with a substance that can be absorbed by activated charcoal (typically psychotropic medications like antidepressants or cardiotropic medications that affect heart function)
  • Your poisoning must be identified by a healthcare professional within 3 hours of admission (if you're already on a breathing machine) or within 3 hours of being put on a breathing machine
  • You must be on a breathing machine (intubated) due to the effects of the poisoning
  • You must have a nasogastric tube (a tube that goes through your nose into your stomach) or be able to have one placed
  • The substance you've taken must be one that can be tested by the toxicology laboratory at Lariboisière Hospital
  • Either you or your family member/trusted person must provide written informed consent. In emergency situations, you may be included without consent initially, but it will be obtained as soon as possible

Who cannot join the trial?

11 criteria

  • Being a minor (under 18 years old)
  • Not having consumed a functional toxicant (substances that affect how your body works, like certain drugs or chemicals)
  • Not being hospitalized in intensive care
  • Not being intubated (having a breathing tube inserted through your mouth into your airway)
  • Being unable to give informed consent or not having a legal representative who can consent on your behalf
  • Having a condition where activated charcoal or intestinal purge would be unsafe
  • Having intestinal obstruction or perforation (blockage or hole in your intestines)
  • Having severe gastrointestinal bleeding
  • Being pregnant or breastfeeding
  • Having already received activated charcoal for the current poisoning before entering the study
  • Participating in another clinical trial that might interfere with this study
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Investigated drugs

The study "DIMREATOX" involves the following treatments: Activated charcoal is a medication used to absorb toxic substances in the digestive system. It works like a sponge to trap chemicals and prevent them from being absorbed into the bloodstream. It's commonly used in cases of poisoning or overdose to help remove harmful substances from the body. Intestinal purge is a treatment that helps clear the contents of the intestines. It typically involves medications that stimulate bowel movements to quickly remove toxins from the digestive tract. This helps eliminate harmful substances before they can be absorbed into the bloodstream.

What is already known about the treatment

  • Activated Charcoal

    A black, fine powder medication that is typically mixed with water and administered orally or via a feeding tube to help absorb toxins in the digestive tract. It is widely recognized in medical literature as an effective adsorbent for many poisons and overdosed medications, binding to them in the stomach and intestines to prevent absorption into the bloodstream. Activated charcoal works by attracting toxins to its large surface area through chemical bonds, effectively trapping them for elimination from the body. It belongs to the class of gastrointestinal adsorbents and is commonly used in emergency medicine for cases of poisoning or drug overdose when the substance was recently ingested.

  • Intestinal Purge

    A medication or solution that stimulates bowel movements to rapidly clear the contents of the intestines, often administered orally or via a feeding tube. In toxicology, intestinal purges (such as polyethylene glycol solutions) are well-established in medical literature for their ability to speed the elimination of toxins from the gastrointestinal tract. These agents work by drawing water into the intestines, creating a flushing effect that moves stool and any unabsorbed toxins through the digestive system more quickly. Intestinal purges belong to the laxative or cathartic class of medications and are used in poisoning cases to complement other decontamination methods by reducing the transit time of toxins in the digestive system.

Investigated diseases

Acute Poisoning – Acute poisoning occurs when a person ingests, inhales, injects, or absorbs through skin contact a toxic substance in sufficient quantity to cause harm. The condition develops rapidly as toxicants enter the bloodstream and affect body systems. Symptoms vary widely depending on the specific toxicant involved, but may include altered mental status, respiratory difficulties, abnormal vital signs, gastrointestinal distress, and organ dysfunction. As the condition progresses, severe cases may lead to respiratory failure requiring mechanical ventilation and intensive care support. The body naturally eliminates toxicants through metabolic processes, but this clearance can be slow for certain substances, allowing continued damage to occur. Toxicants can affect multiple organ systems simultaneously, with the severity depending on the specific substance, amount, and individual factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518739-12-00Protocol codeAPHP231308Estimated enrolment200 patientsSponsorAssistance Publique Hopitaux De Paris

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