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Activated CHARcoal in Poisoned Patient - Pilot Trial

ConditionCharcoal, Decontamination, Poisoning
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorLaval University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Activated Charcoal

    Drug

    Activated charcoal

  • No activated charcoal

    Other intervention

    No activated charcoal

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: AC administrationExperimental treatment 1 intervention
Group B: No ACActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment success

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

Time frame
12 months
2

Protocol adherence

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

Time frame
12 months
3

lost to follow-up

less than 5%

Time frame
12 months

Secondary outcomes

1

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

Time frame
3 months
2

Mortality

Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator

Time frame
3 months
3

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

Time frame
3 months
4

Duration of mechanical ventilation

Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

VITAM - Centre de recherche en santé durable

Collaborator

CHU de Quebec-Universite Laval

Collaborator

Source ClinicalTrials.gov
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