NCT07201311

Combined Gastrointestinal Decontamination in Acute Severe Poisoning

Reduction of Digestive Absorption of Toxic Substances by Combined Digestive Decontamination in Intensive Care - Randomized Single-center Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Severe Poisoning With Cardiotropic or Psychotropic Drug
• Admission to Intensive Care

Interventions

Type	Name	Description
DRUG	Combination of activated charcoal with polyethylene glycol for digestive decontamination	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.
DRUG	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2025-10-01
• Last updated: 2026-01-15

Locations

1 site across 1 country: France