Status:
RECRUITING
A Study on Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning
Lead Sponsor:
University of Edinburgh
Conditions:
Metabolic Acidosis
Eligibility:
All Genders
16+ years
Brief Summary
Methanol poisoning is a serious issue, particularly in low- and middle-income countries (LMICs), where outbreaks can devastate communities. Diagnosing methanol poisoning is challenging because its sym...
Detailed Description
This study group has developed a new method for diagnosing methanol poisoning using a single drop of blood with a point-of-care (POC) device, eliminating the need for laboratory equipment. The device ...
Eligibility Criteria
Inclusion
- • Patients presenting with suspected methanol poisoning or metabolic acidosis of unknown cause, including:
- Children aged 16-17 years, who are willing to provide assent.
- Parents/Guardians of children who are able and willing to provide consent.
- Adults (aged 18 years with no upper age limit) who are willing to provide informed consent.
- Participants who lack capacity to consent for themselves but who have a relative who is willing and able to provide informed consent on behalf of the participant.
- Suspected methanol poisoning will be based on clinician judgement using the following typical indicators of possible methanol ingestion:
- History of:
- Intake of illegal/bootleg/spurious alcohol, and/or
- Other patients admitted with confirmed/suspected methanol poisoning and/or
- Time from intake to symptoms \>6-12 h
- Symptoms/clinical findings
- Coma, and/or
- Hyperventilation (respiratory rate \[RR\] \>20/min) and/or dyspnea, and/or
- Visual disturbances (blurred vision, blindness), and/or
- Gastrointestinal symptoms (vomiting, abdominal pain), and/or
- Chest pain, and/or
- Severe/unusual 'hang-over': Feeling very sick the following day, and/or
- Pseudopapillitis
- Metabolic acidosis of unknown origin will be based on the following features:
- Metabolic acidosis of unknown origin = origin not identified. The acidosis is not of unknown origin if the metabolic acidosis can be explained by another cause eg. lactic acidosis (e.g. where base deficit \[BD\] = 15 mM \[i.e., base excess (BE) = -15 mM\] and lactate is 12-15mM).
- An initial ABG shall be drawn. If the BD is \>15mM (BE\<-15mM), the patient shall be included (as long as "unknown origin" - see above). If the patient has a BD between 5-15, the acidosis is only moderate, and there is time to do the "fluid trial" (see below). If the acidosis improves within 1-2 hours after the fluid trial, the acidosis is unlikely to be because of methanol and the patient should not be included. If the acidosis does not improve, the patient should be included.
Exclusion
- • Children aged 16-17 years, who are unwilling to provide assent.
- Parents/Guardians of children who are unable or unwilling to provide consent.
- Adults (aged 18 years with no upper age limit) who are unwilling to provide informed consent.
- Participants who lack capacity to consent for themselves and who do not have a relative who is willing and able to provide informed consent on behalf of the participant (i.e. unaccompanied unconscious patients and others)
- Individuals previously recruited to the study.
Key Trial Info
Start Date :
June 22 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
6120 Patients enrolled
Trial Details
Trial ID
NCT06881641
Start Date
June 22 2025
End Date
February 28 2028
Last Update
September 26 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
SZMCH
Bogra, Bogura, Bangladesh, 5800
2
Rahshahi medical college hospital
Rajshahi, Rajshahi Division, Bangladesh, 6000
3
Chittagong Medical College Hospital
Chittagong, Bangladesh
4
Dhaka Medical College Hospital
Dhaka, Bangladesh, 1205