Activated charcoal for Acute drug poisoning (intoxication)

Inclusion criteria

• {"criterion_text":"- Patient aged ≥18, intoxicated and hospitalised in intensive care\n- Main drug toxicant of functional type (any psychotropic or cardiotropic), adsorbable by activated charcoal\n- Main toxicant identified by the history taken by a healthcare professional on the ward or during care prior to the ward\n- Main toxicant identified within 3 hours of admission if the patient is already intubated on admission, or within 3 hours of intubation if the patient is intubated on the ward\n- Patient intubated for effects attributed to the toxic agent (neuro-respiratory or haemodynamic failure)\n- Patient with nasogastric tube or planned nasogastric tube and no contraindications\n- Main toxicant whose assay can be performed by the toxicology laboratory at Lariboisière Hospital AND Inclusion according to the emergency clause\n- Written informed consent from a parent/relative/trusted person. In the absence of a parent/relative/trusted person, the patient may be included under the emergency procedure and consent will be obtained as soon as possible."}

Exclusion criteria

• {"criterion_text":"- No social security affiliation\n- Patients under legal protection\n- Patients deprived of their liberty\n- Non-intubated patient\n- Contraindication to the administration of one of the study products (e.g. suspected digestive perforation, intestinal obstruction, inflammatory bowel disease, etc.)\n- Inability to insert a nasogastric tube\n- Repeated vomiting prior to inclusion, making digestive decontamination impossible\n- Digestive haemorrhage in progress or during the previous month\n- Ingestion of metals (e.g. iron, caesium, thallium, lead, copper, cadmium)\n- Isolated or predominant alcohol poisoning (e.g. ethyl alcohol, ethylene glycol, methanol)\n- Intoxication by gas (e.g. carbon monoxide or fire fumes)\n- Intoxication by a caustic product (acids or bases)\n- Main toxicant ingested under liquid form\n- Intoxication by a toxic lesion\n- Intoxication by a non-medicated product (e.g. party drugs)\n- Intubation for causes not attributed to the ingested toxic substance (e.g. massive inhalation pneumonia)\n- In-body carrier of drug pellets\n- Pregnant or breast-feeding patients\n- Patients being treated for dementia\n- Patient under guardianship or curatorship"}

Primary endpoints

• {"endpoint_text":"- Percentage change in the plasma concentration of the toxic substance(s) (ingested parent molecules) at 24 hours compared with its/their value(s) at randomisation.","definition_or_measurement_approach":"Percent change in plasma concentration of the ingested parent toxicant(s) measured at 24 hours post-randomisation compared with the concentration measured at randomisation (baseline)."}

Secondary endpoints

• {"endpoint_text":"- Percentage change in plasma concentration of toxicant(s) (ingested parent molecules) at H48, H72 and H96 compared with the value at randomisation","definition_or_measurement_approach":"Percent change in plasma concentration measured at 48, 72 and 96 hours post-randomisation versus baseline (randomisation)."}
• {"endpoint_text":"- Area under the concentration curve up to the 96th hour expressed as a percentage of the concentration at randomisation","definition_or_measurement_approach":"AUC of plasma concentration up to 96 hours, expressed relative to concentration at randomisation (percent of baseline AUC)."}
• {"endpoint_text":"- Number of days alive without mechanical ventilation for 28 days post-randomisation","definition_or_measurement_approach":"Count of days within the 28-day period post-randomisation during which the participant is alive and not receiving mechanical ventilation."}
• {"endpoint_text":"- Number of days alive without resuscitation for 28 days post-randomisation","definition_or_measurement_approach":"Count of days within the 28-day period post-randomisation during which the participant is alive and not in intensive resuscitation."}
• {"endpoint_text":"- Number of episodes of vomiting","definition_or_measurement_approach":"Total count of vomiting episodes recorded during the study observation period."}
• {"endpoint_text":"- Number of ventilator-associated pneumonias","definition_or_measurement_approach":"Number of diagnosed ventilator-associated pneumonia events during the study follow-up."}
• {"endpoint_text":"- Number of episodes of upper abdominal pain and diarrhoea;","definition_or_measurement_approach":"Count of episodes of upper abdominal pain and of diarrhoea reported during follow-up."}
• {"endpoint_text":"- Presence of hypersensitivity reactions such as anaphylactic shock, angioedema, urticaria, rash and pruritus.","definition_or_measurement_approach":"Occurrence (yes/no) and description of hypersensitivity reactions including anaphylactic shock, angioedema, urticaria, rash and pruritus during treatment and follow-up."}

France

Earliest CTIS Part Ii Submission Date

23-06-2025

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

179

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France