A Phase 2 interventional study of Combination of activated charcoal with polyethylene glycol for digestive decontamination and Standard Treatment (Guideline-Based) in Severe Poisoning With Cardiotropic or Psychotropic Drug and Admission to Intensive Care, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
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.
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. This prolonged absorption is favoured by the large quantity of tablets/pills ingested, the formation of pharmacobezoars, delayed formulations, co-ingestion of transit slowing agents (such as substances with an anticholinergic effect) and mesenteric hypoperfusion in the event of hypotension slowing absorption.
Digestive decontamination with activated charcoal combined with intestinal purging with polyethylene glycol (PEG) appears to be effective in pharmacokinetic studies, but its benefits have never been studied in intoxicated patients, particularly after admission to intensive care. Digestive decontamination using activated charcoal and polyethylene glycol could reduce toxic concentrations at 24 hours compared with the standard treatment group.
Main objective: To show the greatest reduction in the plasma concentration of the toxicant(s) (ingested parent molecules) at H24 of randomisation in the intervention group receiving activated charcoal + intestinal purge compared with the control group.
primary endpoint: 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.
Secondary objectives:
Secondary endpoints:
98 studies on the registry are indexed under Poisoning; 16 are open to participants now.
This study's planned enrollment of 200 is above the median of 46 across 52 interventional studies indexed under Poisoning.
Browse Poisoning studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Patient aged ≥18, intoxicated and hospitalised in intensive care AND
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive activated charcoal and polyethylene glycol
Drug: Combination of activated charcoal with polyethylene glycol for digestive decontamination
Patients receive activated charcoal according to French guidelines
Drug: Standard Treatment (Guideline-Based)
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.
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.
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
Time frame: 24 hours post-randomization
Percentage change in plasma concentration of toxicant
The percentage variation is calculated as: At 48 hours : 100 x (Concentration at 48 hours post-randomization-Concentration at randomization)/ Concentration at randomization At 72 hours : 100 x (Concentration at 48 hours post-randomization-Concentration at randomization)/ Concentration at randomization At 96 hours : 100 x (Concentration at 48 hours post-randomization-Concentration at randomization)/ Concentration at randomization
Time frame: 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
All concentrations up to the 96th hour post-randomization will be used to generate the area under the curve, and this will be reported as percentage of the concentration at randomization
Time frame: 96 hours post-randomization
Number of days alive without mechanical ventilation for 28 days post-randomization
Patients who leave the hospital after extubation and before the 28th day of randomization will be considered as being free of mechanical ventilation from extubation to the 28th day post randomization
Time frame: 28 days post randomization
Number of days alive out of critical care for 28 days post-randomization
This will be defined as the interval from the moment the patient is ready to leave the intensive care until the 28th day of randomization. This will avoid lengthening the theoretical duration of ICU stay due to lack of ward beds
Time frame: 28 days post randomization
The number of vomiting episodes
The polyethylene glycol and activated charcoal may induce vomiting, therefore the number of vomiting episodes will be recorded and compared between groups
Time frame: through the study complétion, an average of 7 days
Number of ventilator-associated pneumonias
Number of pneumonias occurring through the study completion, an average of 7 days
Time frame: through the study complétion, an average of 7 days
Number of episodes of upper abdominal pain
Polyethyleneglycol may cause upper abdominal pain, therefore the number of upper abdominal pain episodes will be recorded and compared between groups
Time frame: through the study complétion, an average of 7 days
Number of episodes of diarrhoea
Diarrhea is a therapeutic effect of the polyethylene glycol, therefore the number of diarrhea episodes will be recorded and compared between groups
Time frame: through the study complétion, an average of 7 days
Presence of hypersensitivity reactions
Polyethylene glycol may cause allergic reactions such as anaphylactic shock, angioedema, urticaria, rash and pruritus, therefore the presence of allergic reactions will be recorded and compared between groups
Time frame: through the study complétion, an average of 7 days
Plan to share: Undecided
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