Combined Gastrointestinal Decontamination in Acute Severe Poisoning

NCT07201311 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: APHP2313082024-518739-12-00
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Severe Poisoning With Cardiotropic or Psychotropic Drug; Admission to Intensive Care

Keywords

Poisoning; Cardiotropic drugs; Psychotropic drugs; Activated charcoal; Polyethylene glycol

Outcome Measures

Primary Outcomes (1)

• Percentage change in the plasma concentration of the toxic substance

  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

  24 hours post-randomization

Secondary Outcomes (9)

• Percentage change in plasma concentration of toxicant

  48, 72 and 96 hours post-randomization

• Area under the concentration curve up to the 96 th hour expressed as a percentage of the concentration at randomization

  96 hours post-randomization

• Number of days alive without mechanical ventilation for 28 days post-randomization

  28 days post randomization

• Number of days alive out of critical care for 28 days post-randomization

  28 days post randomization

• The number of vomiting episodes

  through the study complétion, an average of 7 days

Study Arms (2)

Combined gastrointestinal decontamination

EXPERIMENTAL

Patients receive activated charcoal and polyethylene glycol

Drug: Combination of activated charcoal with polyethylene glycol for digestive decontamination

Control - standard treatment group

ACTIVE COMPARATOR

Patients receive activated charcoal according to French guidelines

Drug: Standard Treatment (Guideline-Based)

Interventions

Combination of activated charcoal with polyethylene glycol for digestive decontamination DRUG

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.

Combined gastrointestinal decontamination

Standard Treatment (Guideline-Based) DRUG

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.

Control - standard treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Sebastian Voicu

Paris, 75010, France

Location

MeSH Terms

Conditions

Poisoning; Anthrax

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Voicu Sebastian, MD

  APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Voicu Sebastian, MD

CONTACT

0149958442; sebastian.voicu@aphp.fr

Megarbane Bruno, Professor

CONTACT

0149958442; bruno.megarbane@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized controlled single-center clinical trial using open-label administration of the study drugs The intervention group will receive activated charcoal at the dose of 25-100g and serial activated charcoal 50g 6 times/day if sustained-release forms or drugs with enterohepatic circulation were ingested. Polyethylene glycol will be administered after activated charcoal at the maximum dose of 1L of polyethylene glycol/15kg of ideal body weight. Treatment with polyethylene glycol will be stopped if clear rectal effluent is observed before 24 hours and/or the maximum dose is reached. The standard treatment group will be treated according to the French guidelines with activated charcoal 25-100g and serial activated charcoal 50g 6 times/day if sustained-release forms or drugs with enterohepatic circulation were ingested.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: October 1, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)