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Activated CHARcoal in Poisoned Patient (CHARPP-RCT)

Primary Purpose

Charcoal, Decontamination, Poisoning

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Activated Charcoal
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Charcoal, Decontamination, Poisoning focused on measuring activated charcoal, decontamination, poisoning, intoxication, toxicity, trial

Eligibility Criteria

0 Years - 125 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who presented to the hospital less than 8h after the ingestion of a potentially toxic dose of a carbo-adsorbable substance

Exclusion Criteria:

  • Patients requiring or who will likely require another gastro-intestinal decontamination method;
  • who have a contraindication to receive AC;
  • who ingested a substance with an entero-hepatic circulation requiring multi-dose AC.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    AC as per the Clinical Toxicology Recommendations Collaborative recommendations

    AC as per current practice

    Arm Description

    Outcomes

    Primary Outcome Measures

    recruitment success
    100 patients total at the two poison centers associated with academic hospitals and greater than one patient enrolled/hospital/month
    protocol adherence
    at least 95% of the patient randomized in the CTRC recommendations 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
    lost to follow-up
    less than 5%

    Secondary Outcome Measures

    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
    mortality
    length of stay in the intensive care unit and hospital
    duration of mechanical ventilation
    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)
    adverse events

    Full Information

    First Posted
    July 14, 2022
    Last Updated
    July 20, 2022
    Sponsor
    Laval University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05471479
    Brief Title
    Activated CHARcoal in Poisoned Patient
    Acronym
    CHARPP-RCT
    Official Title
    CHARPP (Activated CHARcoal in Poisoned Patient): RCT Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Laval University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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 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 risks and benefits associated with the use of AC. The Clinical Toxicology Recommendations Collaborative (CTRC) already published a systematic review and is currently working on recommendations of use. 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 as per the CTRC recommendations 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 as per the CTRC recommendations and who received AC as per current practice. The targeted primary outcomes includes: 1) recruitment success (100 patients total at the two poison centers associated with academic hospitals and greater than one patient enrolled/hospital/month), 2) protocol adherence (at least 95% of the patient randomized in the CTRC recommendations 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) lost to follow-up (less than 5%). As secondary outcomes, progression of toxicity measured by the Poison Severity Score (and the SOFA score for adults or PELODS score for children), mortality, length of stay in the intensive care unit and hospital, duration of mechanical ventilation, functional outcomes and adverse events will also be described for both groups. METHODS: This randomized concealed multicenter trial will take place in at least two poison centres and at least four Canadian academic hospitals including at least one pediatric center. Patients who presented to the hospital less than 8h after the ingestion of a potentially toxic dose of a carbo-adsorbable substance 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. The specialist in poison information will then refer either to the CTRC recommendations or to their current protocols for the use of AC. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Charcoal, Decontamination, Poisoning
    Keywords
    activated charcoal, decontamination, poisoning, intoxication, toxicity, trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    850 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AC as per the Clinical Toxicology Recommendations Collaborative recommendations
    Arm Type
    Experimental
    Arm Title
    AC as per current practice
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Activated Charcoal
    Intervention Description
    Activated charcoal administered as per Clinical Toxicology Recommendations Collaborative or as per current practices
    Primary Outcome Measure Information:
    Title
    recruitment success
    Description
    100 patients total at the two poison centers associated with academic hospitals and greater than one patient enrolled/hospital/month
    Time Frame
    6 months
    Title
    protocol adherence
    Description
    at least 95% of the patient randomized in the CTRC recommendations 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
    Time Frame
    6 months
    Title
    lost to follow-up
    Description
    less than 5%
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    progression of toxicity (descriptive measure of delta Poison Severity Score - PSS max - PSS at randomization calculated at the end of each case)
    Description
    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
    6 months
    Title
    mortality
    Time Frame
    6 months
    Title
    length of stay in the intensive care unit and hospital
    Time Frame
    6 months
    Title
    duration of mechanical ventilation
    Time Frame
    6 months
    Title
    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)
    Time Frame
    6 months
    Title
    adverse events
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    125 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who presented to the hospital less than 8h after the ingestion of a potentially toxic dose of a carbo-adsorbable substance Exclusion Criteria: Patients requiring or who will likely require another gastro-intestinal decontamination method; who have a contraindication to receive AC; who ingested a substance with an entero-hepatic circulation requiring multi-dose AC.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maude St-Onge, MD PhD FRCPC
    Phone
    418-932-5357
    Email
    maude.st-onge.med@ssss.gouv.qc.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maude St-Onge, MD PhD FRCPC
    Organizational Affiliation
    CHU de Québec - Université Laval
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Activated CHARcoal in Poisoned Patient

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