CHARPP-RCT: Activated CHARcoal in Poisoned Patient

Sponsor

Laval University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05471479

Collaborator

(none)

850

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Charcoal, Decontamination, Poisoning	Drug: Activated Charcoal	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

850 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AC as per the Clinical Toxicology Recommendations Collaborative recommendations	Drug: Activated Charcoal Activated charcoal administered as per Clinical Toxicology Recommendations Collaborative or as per current practices
Active Comparator: AC as per current practice	Drug: Activated Charcoal Activated charcoal administered as per Clinical Toxicology Recommendations Collaborative or as per current practices

Arm

Intervention/Treatment

Experimental: AC as per the Clinical Toxicology Recommendations Collaborative recommendations

Drug: Activated Charcoal

Activated charcoal administered as per Clinical Toxicology Recommendations Collaborative or as per current practices

Active Comparator: AC as per current practice

Drug: Activated Charcoal

Activated charcoal administered as per Clinical Toxicology Recommendations Collaborative or as per current practices

Outcome Measures

Primary Outcome Measures

recruitment success [6 months]
100 patients total at the two poison centers associated with academic hospitals and greater than one patient enrolled/hospital/month
protocol adherence [6 months]
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 [6 months]
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) [6 months]
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 [6 months]
length of stay in the intensive care unit and hospital [6 months]
duration of mechanical ventilation [6 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]
adverse events [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 125 Years

Sexes Eligible for Study:

All

Accepts 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.