Activated CHARcoal in Poisoned Patient - Pilot Trial (CHARPP-Pilot)

CHARPP (Activated CHARcoal in Poisoned Patient): RCT Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Charcoal, Decontamination, Poisoning
• Intervention / Treatment: Drug: Activated Charcoal; Other: No activated charcoal

Detailed Description

BACKGROUND: Activated charcoal (AC) is one of the interventions more frequently recommended by poison centers. For instance, in 2020, 32,646 poisoned patients were treated with AC in the United States. This decontamination method has the potential to prevent toxicity and to decrease its severity, but its use is also associated with adverse effects and has a poor palatability. Therefore, we developed a research program named CHARPP (activated CHARcoal in Poisoned Patients) aiming to describe the effect and potential risks associated with the use of AC. This study is particularly focused on whether early administration of activated charcoal can reduce the severity of poisoning outcomes, shorten hospital stays, and mitigate healthcare costs.The first phase of our research program included: a retrospective study and a validation of the Poison Severity Score. The last phase includes a randomized controlled trial (RCT) preceded by a feasibility study in adults and children to compare outcomes in patients who received AC vs those who did not.

OBJECTIVES: This concerns the CHARPP RCT feasibility study which aims to evaluate the possibility of conducting a large multicenter RCT comparing outcomes between poisoned patients who received AC and who did not received AC. The targeted primary outcomes includes: 1) recruitment success (100 patients total at the poison centre associated with hospitals and greater than one patient enrolled/hospital/month), 2) protocol adherence (at least 85% of the patient randomized in the intervention group received AC in less than two hours after group allocation if AC was recommended or did not received it if it was not recommended) and, 3) Less than 5% loss to follow-up. As for the large-scale clinical trial if pilot trial shows feasability, the primary outcome will be progression of toxicity as measured using the Poison Severity Score, a patient-oriented metric frequently used in toxicology; mortality, length of stay in both the intensive care unit and hospital, quality of life as measured by the EQ-5D-5L, and changes in the SOFA score for adults and the PELODS score for children.

METHODS: This randomized concealed multicenter trial will take place in one poison centre and five academic hospitals within the provincial network of the centre antipoison du Québec. Patients presenting to the Emergency rooms with a proven or suspected ingestion of a substance absorbed by activated charcoal and the ones who can receive the intervention within 6 hours of proven or suspected intoxication will be included. Patients requiring or who will likely require another gastro-intestinal decontamination method, who have a contraindication to receive AC, or who ingested a substance with an entero-hepatic circulation requiring multi-dose AC will be excluded. Once the poison centre has identified an eligible patient, we will use a web-based system to perform a randomization in random blocks of two or four. Co-interventions will be standardized as per the poison centre protocols. Follow up will be done every 8h by the poison centres who will also collect data regarding progression of toxicity and relevant outcomes. The research assistant who will extract data will be blinded to study allocation. Only a descriptive analysis will be done for the pilot trial. Data from paediatric patients will be analysed separately. A data and safety monitoring board independent from the study group will follow the results and approve or not the continuation of the study.

RELEVANCE: This will be an excellent opportunity to develop collaborations between poison centers and key actors who will be involved in a larger trial. The results of the research program CHARPP have the potential to influence policies, poison centers recommendations, clinicians' practices and to improve poisoned patients' outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maude St-Onge, Md PhD FRCPC; Phone Number: 418-932-5357; Email: maude.st-onge.med@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1J1Z4
      • Recruiting
      • CHU de Québec - Université Laval
      • Contact: Maude St-Onge, Md PhD FRCPC; Phone Number: 418-932-5357; Email: maude.st-onge.med@ssss.gouv.qc.ca
      • Contact: Audrée Elliott, BPharm, MSc; Phone Number: 418-573-8799; Email: audree.elliott.ciusscn@ssss.gouv.qc.ca
      • Principal Investigator: Maude St-Onge, Md PhD FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 125 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AC administration; 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; Activated charcoal; Other Names: AC
Active Comparator: No AC; Participants will not receive any activated charcoal	Other: No activated charcoal; No activated charcoal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of toxicity (descriptive measure of delta Poison Severity Score - PSS max - PSS at randomization calculated at the end of each case)	measured by the delta Poison Severity Score (min = 0 - better outcome; max = 4 - worse outcome) (and the SOFA - sequential organ failure assessment - score for adults or PELOD -paediatric logistic organ dysfunction - score for children) and available drug levels	3 months
Mortality	Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator	3 months
Length of stay in the intensive care unit and hospital	Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator	3 months
Duration of mechanical ventilation	Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator	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)	The ability of patients to return to their daily lives and activities after treatment. Specifically, the trial looks at whether patients can return to their original residence without help and manage personal hygiene tasks such as toileting independently. Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator	6 months
adverse events	Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator	3 months

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Canadian Institutes of Health Research (CIHR); CHU de Quebec-Universite Laval; VITAM - Centre de recherche en santé durable
• Investigators: Principal Investigator: Maude St-Onge, MD PhD FRCPC, CHU de Québec - Université Laval

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: clinical trial; toxicity; activated charcoal; decontamination; poisoning; intoxication; Emergency medicine; toxicology; PROBE trial
• Additional Relevant MeSH Terms: Infections; Chemically-Induced Disorders; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Bacillaceae Infections; Poisoning; Anthrax; Inorganic Chemicals; Elements; Carbon; Charcoal
• Other Study ID Numbers: CHARPP - pilot study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
• IPD Sharing Time Frame: Feb 2025 up to 6months after publication
• IPD Sharing Access Criteria: Any scientists
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No