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
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
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
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
Learn more about this trial
Activated CHARcoal in Poisoned Patient
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