BridgeMD
New treatment option for Severe Poisoning With Cardiotropic or Psychotropic Drug
Official title Combined Gastrointestinal Decontamination in Acute Severe Poisoning
ClinicalTrials.gov ID: NCT07201311
What this study is testing
What is Combination of activated charcoal with polyethylene glycol for digestive decontamination?
Combination of activated charcoal with polyethylene glycol for digestive decontamination is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for severe poisoning with cardiotropic or psychotropic drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patient intubated for effects attributed to the toxic agent (neuro-respiratory or haemodynamic failure) AND
You likely can't join 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...
- Inability to insert a nasogastric tube
- Repeated vomiting prior to inclusion, making digestive decontamination impossible
- Digestive haemorrhage in progress or during the previous month
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.