drugset / Trial / NCT07201311

Combined Gastrointestinal Decontamination in Acute Severe Poisoning

NCT07201311

Phase 2 Recruiting 200 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

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. 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.

Timeline

Start
2026-06-24
Primary completion
2028-06-24
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject polyethylene glycol Other / unclassified 1000 ml
Background Activated Charcoal Other / unclassified 25 g Other
Background Activated Charcoal Other / unclassified 50 g Other
Background Activated Charcoal Other / unclassified 100 g Other

Indications