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Search / Trial NCT06881641

A Study on Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning

Launched by UNIVERSITY OF EDINBURGH · Mar 17, 2025

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Methanol Toxicity

ClinConnect Summary

This clinical trial is studying a new, simple test to diagnose methanol poisoning, a serious condition that can occur when someone drinks contaminated alcohol. Methanol itself is not very harmful, but when the body breaks it down, it produces a toxic substance that can cause severe health issues, including brain swelling and death. The new test only requires a single drop of blood and can be done right at the bedside, making it much faster and easier to diagnose compared to traditional lab tests that can take hours. The study aims to see how well this test works compared to standard methods and whether it can help doctors diagnose and treat patients more quickly, potentially saving lives.

To participate in the trial, patients must show signs of suspected methanol poisoning or metabolic acidosis (a condition where there is too much acid in the body) of unknown cause. This includes young people aged 16-17 who can agree to join, as well as adults over 18 who can give their consent. Participants will be closely monitored, and the trial will help researchers learn if this new test can be used effectively in hospitals. It's important to note that individuals who have already been part of the study cannot join again. This trial is not yet recruiting participants, so more information will be available soon.

Gender

ALL

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.

About University Of Edinburgh

The University of Edinburgh, a prestigious institution renowned for its commitment to research excellence and innovation, serves as a leading clinical trial sponsor dedicated to advancing healthcare through rigorous scientific inquiry. With a strong emphasis on multidisciplinary collaboration, the university facilitates cutting-edge clinical studies that aim to explore novel therapies and improve patient outcomes. Leveraging its extensive network of researchers, healthcare professionals, and state-of-the-art facilities, the University of Edinburgh is at the forefront of translating scientific discoveries into practical applications, thereby contributing significantly to the global medical community.

Locations

Chittagong, , Bangladesh

Sylhet, , Bangladesh

Chandigarh, , India

Patients applied

0 patients applied

Trial Officials

Prof Michael Eddleston

Study Chair

University of Edinburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported