2024-518739-12-00招募中2 期
DIMREATOX study - Reduction in digestive absorption of toxic substances by combined digestive decontamination in intensive care - randomized single-center study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient aged ≥18, intoxicated and hospitalised in intensive care
- •Main drug toxicant of functional type (any psychotropic or cardiotropic), adsorbable by activated charcoal
- •Main toxicant identified by the history taken by a healthcare professional on the ward or during care prior to the ward
- •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
- •Patient intubated for effects attributed to the toxic agent (neuro-respiratory or haemodynamic failure)
- •Patient with nasogastric tube or planned nasogastric tube and no contraindications
- •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.
排除标准
- •No social security affiliation
- •Patients under legal protection
- •Patients deprived of their liberty
- •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
结局指标
主要结局
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.
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.
次要结局
- 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.
研究者
Investigateur coordonnateur
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
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