Status:
NOT_YET_RECRUITING
Combined Gastrointestinal Decontamination in Acute Severe Poisoning
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Severe Poisoning With Cardiotropic or Psychotropic Drug
Admission to Intensive Care
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Gastrointestinal absorption of high dose medication (toxicant) ingested under solid form for suicidal purposes, is prolonged in patients who need intensive care admission and mechanical ventilation. T...
Detailed Description
Rationale - digestive absorption of toxic substances ingested in solid form is prolonged in severely intoxicated patients admitted to intensive care and requiring intubation and mechanical ventilation...
Eligibility Criteria
Inclusion
- Patient aged ≥18, intoxicated and hospitalised in intensive care AND
- Main drug toxicant of functional type (any psychotropic or cardiotropic), adsorbable by activated charcoal And
- Main toxicant identified by the history taken by a healthcare professional on the ward or during care prior to the ward And
- 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 AND
- Patient intubated for effects attributed to the toxic agent (neuro-respiratory or haemodynamic failure) AND
- Patient with nasogastric tube or planned nasogastric tube and no contraindications AND
- Main toxicant whose assay can be performed by the toxicology laboratory at Lariboisière Hospital AND Inclusion according to the emergency clause
- 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
- No social security affiliation
- Non-intubated patient
- Contraindication to the administration of one of the study products (e.g. suspected digestive perforation, intestinal obstruction, inflammatory bowel disease, etc.)
- Inability to insert a nasogastric tube
- Repeated vomiting prior to inclusion, making digestive decontamination impossible
- Digestive haemorrhage in progress or during the previous month
- Ingestion of metals (e.g. iron, caesium, thallium, lead, copper, cadmium)
- Isolated or predominant alcohol poisoning (e.g. ethyl alcohol, ethylene glycol, methanol)
- Intoxication by gas (e.g. carbon monoxide or fire fumes)
- Intoxication by a caustic product (acids or bases)
- Main toxicant ingested under liquid form
- Intoxication by a toxic lesion
- Intoxication by a non-medicated product (e.g. party drugs)
- Intubation for causes not attributed to the ingested toxic substance (e.g. massive inhalation pneumonia)
- In-body carrier of drug pellets
- Pregnant or breast-feeding patients
- Patients being treated for dementia
- Patient under guardianship or curatorship
- Patients under legal protection
- Patients deprived of their liberty
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07201311
Start Date
November 1 2025
End Date
November 1 2027
Last Update
October 1 2025
Active Locations (1)
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1
Sebastian Voicu
Paris, France, 75010