Activated CHARcoal in Poisoned Patient - Pilot Trial

NCT05471479 | Recruiting Phase 4 DMC

• 1 other identifier: CHARPP - pilot study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical pilot trial is to determine the feasibility of the clinical trial. Then the large-scale CHARPP will be conducted in order to determine the efficacity of activated charcoal as a treatment for acute poisoning in a diverse population of both adults and children suspected of ingesting toxic substances that activated charcoal can adsorb. The main questions it aims to answer are:

• Can activated charcoal administered within a specific time frame prevent the progression of toxicity?
• How does activated charcoal affect the length of stay in the hospital and the intensive care unit? Researchers will compare the intervention arm (receiving activated charcoal) to the control arm (receiving standard supportive care) to see if activated charcoal reduces hospital stay duration, ICU stay and improves overall patient outcomes. Participants will:
• Be randomly assigned to either receive activated charcoal or standard supportive care.
• Undergo assessments using standardized clinical scales such as the Poison Severity Score and, for children, the PELODS score.
• Have their functional outcomes evaluated, such as the ability to return to their original residence without help and manage personal hygiene tasks independently. This structured approach will help clarify the role of activated charcoal in clinical toxicology and inform future treatment protocols.

Conditions

Charcoal, Decontamination, Poisoning

Keywords

activated charcoal; decontamination; poisoning; intoxication; toxicity; clinical trial; toxicology; Emergency medicine; PROBE trial

Outcome Measures

Primary Outcomes (3)

• Recruitment success

  100 patients total at the poison centre associated with hospitals and greater than one patient enrolled/hospital/month

  12 months

• Protocol adherence

  at least 85% of the patient randomized in the intervention group

  12 months

• lost to follow-up

  less than 5%

  12 months

Secondary Outcomes (6)

• Progression of toxicity (descriptive measure of delta Poison Severity Score - PSS max - PSS at randomization calculated at the end of each case)

  3 months

• Mortality

  3 months

• Length of stay in the intensive care unit and hospital

  3 months

• Duration of mechanical ventilation

  3 months

• functional outcomes (descriptive measure: "back to baseline" or "not back to baseline" calculated at the moment of medical discharge, death or decision of withdrawal of life support)

  6 months

Study Arms (2)

AC administration

EXPERIMENTAL

Participants will receive 1g/kg up to a maximum of 50g of activated charcoal by mouth or by naso-gastric tube. The intervention is giving over 15 minutes, as recommended. Activated charcoal can be mixed in a black soft drink to improve palatability and treatment adherence which is often done in usual practice.

Drug: Activated Charcoal

No AC

ACTIVE COMPARATOR

Participants will not receive any activated charcoal

Other: No activated charcoal

Interventions

Activated Charcoal DRUG

Activated charcoal

Also known as: AC

AC administration

No activated charcoal OTHER

No activated charcoal

No AC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult and pediatric patients who presented to the hospital less than 6h after the ingestion of a potentially toxic dose of a carbo-adsorbable substance (substance adsorbed by activated charcoal ).
• Patients who can receive the intervention within 6 hours of proven or suspected intoxication

You may not qualify if:

• Patients requiring or who will likely require another gastro-intestinal decontamination method;
• Patients who have contraindication to the use of activated charcoal;
• Patients who ingested a substance with an entero-hepatic circulation requiring multi-dose AC;
• Patients who have no clinical equipoise for the use of activated charcoal as per the attending physician.

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• VITAM - Centre de recherche en santé durable: collaborator
• CHU de Quebec-Universite Laval: collaborator

Study Sites (1)

CHU de Québec - Université Laval

Québec, Quebec, G1J1Z4, Canada

RECRUITING

MeSH Terms

Conditions

Anthrax; Poisoning

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Maude St-Onge, MD PhD FRCPC

  CHU de Québec - Université Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maude St-Onge, MD PhD FRCPC

CONTACT

418-932-5357; maude.st-onge.med@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data Analysts: These individuals are responsible for processing and analyzing the collected data. They are blinded to the group allocations to ensure that their analyses are unbiased. Research Assistants: Those involved in collecting trial data from participants, including demographics, medical history, and treatment outcomes, are also blinded to the allocation groups.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Clinician-scientist

Model Details: The CHARPP pilot trial employs a Prospective Randomized Open Blinded End-point (PROBE) interventional study model. The study is designed to follow participants forward in time after their enrollment, with interventions and outcomes measured as they occur. Participants are randomly assigned to either the intervention group, which receives activated charcoal, or the control group, which does not receive activated charcoal. This randomization helps to minimize selection bias and balance known and unknown confounding factors across the study groups. The nature of the intervention (activated charcoal) makes it impractical to blind the participants or the clinicians administering the treatment, as the substance visibly changes the color of the oral mucosa to black. While the immediate caregivers and participants know the treatment allocation due to the visible nature of activated charcoal, the outcome assessors and data analysts are blinded to the group assignment.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 22, 2022
• Study Start: July 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Feb 2025 up to 6months after publication
• Access Criteria: Any scientists

Locations

CA (1)