DIMREATOX study - Reduction in digestive absorption of toxic substances by combined digestive decontamination in intensive care - randomized single-center study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2025-07-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Project funded by the CRC 2023

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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.

Secondary objectives 3

1. - To show the greatest 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;
2. - 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;
3. - To demonstrate the good tolerance of treatment by digestive decontamination in the intervention group.

Conditions and MedDRA coding

Major patients intoxicated by functional toxicant(s), hospitalized in intensive care and intubated.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patient aged ≥18, intoxicated and hospitalised in intensive care
2. Main drug toxicant of functional type (any psychotropic or cardiotropic), adsorbable by activated charcoal
3. Main toxicant identified by the history taken by a healthcare professional on the ward or during care prior to the ward
4. 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
5. Patient intubated for effects attributed to the toxic agent (neuro-respiratory or haemodynamic failure)
6. Patient with nasogastric tube or planned nasogastric tube and no contraindications
7. Main toxicant whose assay can be performed by the toxicology laboratory at Lariboisière Hospital AND Inclusion according to the emergency clause
8. 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 20

1. - No social security affiliation
2. Intoxication by a caustic product (acids or bases)
3. Intoxication by a toxic lesion
4. Intoxication by a non-medicated product (e.g. party drugs)
5. Intubation for causes not attributed to the ingested toxic substance (e.g. massive inhalation pneumonia)
6. - In-body carrier of drug pellets
7. - Pregnant or breast-feeding patients
8. - Patients being treated for dementia
9. - Patient under guardianship or curatorship
10. - Patients under legal protection
11. - Patients deprived of their liberty
12. - Non-intubated patient
13. Contraindication to the administration of one of the study products (e.g. suspected digestive perforation, intestinal obstruction, inflammatory bowel disease, etc.)
14. - Inability to insert a nasogastric tube
15. Repeated vomiting prior to inclusion, making digestive decontamination impossible
16. - Digestive haemorrhage in progress or during the previous month
17. Ingestion of metals (e.g. iron, caesium, thallium, lead, copper, cadmium)
18. - Isolated or predominant alcohol poisoning (e.g. ethyl alcohol, ethylene glycol, methanol)
19. - Intoxication by gas (e.g. carbon monoxide or fire fumes)
20. - Main toxicant ingested under liquid form

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 8

1. Percentage change in plasma concentration of toxicant(s) (ingested parent molecules) at H48, H72 and H96 compared with the value at randomisation
2. Area under the concentration curve up to the 96th hour expressed as a percentage of the concentration at randomisation
3. Number of days alive without mechanical ventilation for 28 days post-randomisation
4. Number of days alive without resuscitation for 28 days post-randomisation
5. Number of episodes of vomiting
6. Number of ventilator-associated pneumonias
7. Number of episodes of upper abdominal pain and diarrhoea;
8. Presence of hypersensitivity reactions such as anaphylactic shock, angioedema, urticaria, rash and pruritus.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Investigateur coordonnateur

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Investigateur coordonnateur

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications