NCT06881641 A Study on Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning
| NCT ID | NCT06881641 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Metabolic Acidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,120 participants |
| Start Date | 2025-06-22 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,120 participants in total. It began in 2025-06-22 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 symptoms mimic many other conditions, and traditional diagnostic methods require expensive lab equipment. Unfortunately, this often means doctors do not even consider methanol poisoning as a diagnosis. Methanol itself isn't highly toxic, but when the body breaks it down into formate, it becomes dangerous, leading to brain swelling and even death. To address this, a study team has developed a new method to diagnose methanol poisoning using a single drop of blood with a device that can be used at the bedside, eliminating the need for any lab equipment. This point-of-care (POC) test measures formate, which is only present in cases of methanol poisoning. The project consists of two sequential studies. The first study aims to compare the effectiveness of the POC formate test against standard lab tests, which can take several hours. The findings from this study will inform the second study. The second study is a feasibility cluster randomized controlled trial. In this trial, entire hospitals, rather than individual patients, are randomly assigned different approaches, similar to tossing a coin. The goal is to determine whether this trial design can be used in larger-scale research to evaluate clinical outcomes. Specifically, it will examine whether the POC formate test can accelerate accurate diagnosis, enabling prompt treatment and preventing deaths.
Eligibility Criteria
Inclusion Criteria: • 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: 1. 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 2. 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 Criteria: * • 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.
Contact & Investigator
Prof Michael Eddleston
STUDY CHAIR
University of Edinburgh
Frequently Asked Questions
Who can join the NCT06881641 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Metabolic Acidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06881641 currently recruiting?
Yes, NCT06881641 is actively recruiting participants. Contact the research team at M.Eddleston@ed.ac.uk for enrollment information.
Where is the NCT06881641 trial being conducted?
This trial is being conducted at Bogra, Bangladesh, Rajshahi, Bangladesh, Chittagong, Bangladesh, Dhaka, Bangladesh and 2 additional locations.
Who is sponsoring the NCT06881641 clinical trial?
NCT06881641 is sponsored by University of Edinburgh. The principal investigator is Prof Michael Eddleston at University of Edinburgh. The trial plans to enroll 6,120 participants.