Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05471479
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-07-22
First Post:
2022-07-14
Brief Title:
Activated CHARcoal in Poisoned Patient
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
CHARPP Activated CHARcoal in Poisoned Patient RCT Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHARPP-RCT
Brief Summary:
BACKGROUND Activated charcoal AC is one of the interventions more frequently recommended by poison centers For instance in 2020 32646 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 enrolledhospitalmonth 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
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 enrolledhospitalmonth 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None