Combined Gastrointestinal Decontamination in Acute Severe Poisoning

NCT07201311 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 2

Started

2026-06-24

Last updated

2026-07-06

Condition(s) studied

Severe Poisoning With Cardiotropic or Psychotropic DrugAdmission to Intensive Care

Investigational drug(s) / intervention(s)

Combination of activated charcoal with polyethylene glycol for digestive decontaminationStandard Treatment (Guideline-Based)

Combination of activated charcoal with polyethylene glycol for digestive decontamination: A dose of 25-100g of activated charcoal via the nasogastric tube will be administered, followed by polyethylene glycol1L/15-20 kg ideal body weight at a flow rate of 1L/hour. polyethylene glycol will be continued until clear stools are obtained, a maximum of 24h of treatment of until the maximum dose of 1L per 15 kg of ideal body weight are administered. Serial activated charcoal 50g 6 times/day will be administered if prolonged-release forms or drugs with enterohepatic circulation were ingested.

Standard Treatment (Guideline-Based): Patients receive activated charcoal according to French guidelines - activated charcoal 25-100g and serial activated charcoal 50g 6 times/day if sustained-release forms or drugs with enterohepatic circulation as routine treatment.

Study 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. This is due to the large ingested amounts, slowed blood circulation in the digestive system due to low blood pressure, and the formation of conglomerates of pills (pharmacobezoars).

We make the hypothesis that combined decontamination of the digestive system with activated charcoal plus polyethylene glycol may reduce absorption of the ingested toxicant compared with standard care.

Two hundred patients requiring admission to intensive care and mechanical ventilation due to the effect of the ingested toxicant, will be included in a 1:1 randomized fashion over 24 months in the intervention group receiving combined decontamination and standard care group receiving activated charcoal according to guidelines.

The main objective is to show a decrease in the concentration of the toxicant after 24h of randomization.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 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 Criteria: * 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

Primary outcome measure(s)

Percentage change in the plasma concentration of the toxic substance — 24 hours post-randomization
The primary endpoint is the percentage change in the plasma concentration of the toxic substance at 24 hours compared with the value at randomization. The percentage variation is calculated as 100 x (Concentration at 24 hours post-randomization-Concentration at randomization)/ Concentration at randomization

Trial sites (1)

Facility	City	Region	Status
Sebastian Voicu	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07201311 on ClinicalTrials.gov ↗ ← All trials in France