Severe Poisoning With Cardiotropic or Psychotropic DrugPhase 2DIMREATOXNCT07201311
Combined Gastrointestinal Decontamination in Acute Severe Poisoning
A Phase 2 study testing Combination of activated charcoal with polyethylene glycol for digestive decontamination and Standard Treatment (Guideline-Based) in people with Severe Poisoning With Cardiotropic or Psychotropic Drug and Admission to Intensive Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Poisoning With Cardiotropic or Psychotropic Drug, Admission to Intensive Care
- What is being tested?
- Combination of activated charcoal with polyethylene glycol for digestive decontamination and Standard Treatment (Guideline-Based)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2026to Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Sebastian Voicu
Paris, 75010
Voicu Sebastian, MD, 0149958442 ext. +33, sebastian.voicu@aphp.fr
About this study
Official title: Reduction of Digestive Absorption of Toxic Substances by Combined Digestive Decontamination in Intensive Care - Randomized Single-center Study
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.
Read more
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.
Read the 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. 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:
- To show the greater reduction in the plasma concentration of the toxic substance(s) (ingested parent molecules) at H48, H72 and H96 of randomisation in the intervention group compared with the control group;
- To demonstrate a reduction in the number of days of mechanical ventilation and the length of time spent in intensive care in the intervention group compared with the control group;
- To demonstrate the good tolerance of treatment by digestive decontamination in the intervention group.
Secondary endpoints:
- Percentage change in plasma concentration of toxicant(s) (ingested parent molecules) at H48, H72 and H96 compared with the value at randomisation
- Area under the concentration curve up to the 96th hour expressed as a percentage of the concentration at randomisation
- Number of days alive without mechanical ventilation for 28 days post-randomisation
- Number of days alive without resuscitation for 28 days post-randomisation
- Number of episodes of vomiting
- Number of ventilator-associated pneumonias
- Number of episodes of upper abdominal pain and diarrhoea;
- Presence of hypersensitivity reactions such as anaphylactic shock, angioedema, urticaria, rash and pruritus.
- Being tested
- Combination of activated charcoal with polyethylene glycol for digestive decontamination, Standard Treatment (Guideline-Based)
- Keywords
- Poisoning, Cardiotropic drugs, Psychotropic drugs, Activated charcoal, Polyethylene glycol
- Medical subject headings
- Poisoning, Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of activated charcoal with polyethylene glycol for digestive decontaminationDrug
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Combined gastrointestinal decontamination | Experimental | Patients receive activated charcoal and polyethylene glycol Receives: 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 Receives: Drug: Standard Treatment (Guideline-Based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours post-randomization
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through the study complétion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start24 Jun 2026
- Primary completion24 Jun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Poisoning With Cardiotropic or Psychotropic DrugStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Voicu Sebastian, MD, Principal investigator, APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201311
- Sponsor's protocol ID
- APHP231308
- Other IDs
- 2024-518739-12-00
- Acronym
- DIMREATOX
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Digestive Absorption of Toxic Substances by Combined Digestive Decontamination in Intensive Care - Randomized Single-center Study
- ClinicalTrials.gov ID
- NCT07201311
- Acronym / sponsor ID
- DIMREATOX / APHP231308
- Keywords
- Poisoning, Cardiotropic drugs, Psychotropic drugs, Activated charcoal, Polyethylene glycol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 24 Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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:
- To show the greater reduction in the plasma concentration of the toxic substance(s) (ingested parent molecules) at H48, H72 and H96 of randomisation in the intervention group compared with the control group;
- To demonstrate a reduction in the number of days of mechanical ventilation and the length of time spent in intensive care in the intervention group compared with the control group;
- To demonstrate the good tolerance of treatment by digestive decontamination in the intervention group.
Secondary endpoints:
- Percentage change in plasma concentration of toxicant(s) (ingested parent molecules) at H48, H72 and H96 compared with the value at randomisation
- Area under the concentration curve up to the 96th hour expressed as a percentage of the concentration at randomisation
- Number of days alive without mechanical ventilation for 28 days post-randomisation
- Number of days alive without resuscitation for 28 days post-randomisation
- Number of episodes of vomiting
- Number of ventilator-associated pneumonias
- Number of episodes of upper abdominal pain and diarrhoea;
- Presence of hypersensitivity reactions such as anaphylactic shock, angioedema, urticaria, rash and pruritus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combined gastrointestinal decontamination | Experimental | Drug: Combination of activated charcoal with polyethylene glycol for digestive decontaminationPatients receive activated charcoal and polyethylene glycol |
| Control - standard treatment group | Active comparator | Drug: Standard Treatment (Guideline-Based)Patients receive activated charcoal according to French guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of activated charcoal with polyethylene glycol for digestive decontaminationA 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. | Drug | Combined gastrointestinal decontamination |
| 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. | Drug | Control - standard treatment group |
Primary outcome
Percentage change in the plasma concentration of the toxic substance
Time frame: 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
9 secondary outcomes
Percentage change in plasma concentration of toxicant
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
Time frame: 96 hours post-randomization
Number of days alive without mechanical ventilation for 28 days post-randomization
Time frame: 28 days post randomization
Number of days alive out of critical care for 28 days post-randomization
Time frame: 28 days post randomization
The number of vomiting episodes
Time frame: through the study complétion, an average of 7 days
Number of ventilator-associated pneumonias
Time frame: through the study complétion, an average of 7 days
Number of episodes of upper abdominal pain
Time frame: through the study complétion, an average of 7 days
Number of episodes of diarrhoea
Time frame: through the study complétion, an average of 7 days
Presence of hypersensitivity reactions
Time frame: through the study complétion, an average of 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Voicu Sebastian, MD principal investigator
APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of activated charcoal with polyethylene glycol for digestive decontamination and Standard Treatment (Guideline-Based) in people with Severe Poisoning With Cardiotropic or Psychotropic Drug and Admission to Intensive Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Voicu Sebastian, MD (0149958442 ext. +33, sebastian.voicu@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in the plasma concentration of the toxic substance (time frame: 24 hours post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.