Bedside formate test to diagnose methanol poisoning

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project develops a point-of-care device that measures blood formate from a single drop to diagnose methanol poisoning without laboratory equipment. Study 1a is an observational comparison of the POC formate assay against the laboratory formate assay to determine sensitivity and specificity. If Study 1a shows sensitivity above 0.80, Study 1b will test the feasibility of a three-arm cluster randomized controlled trial comparing diagnostic approaches. The overall plan is to use this phased approach to inform later trials of clinical- and cost-effectiveness in routine care, especially in low-resource settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Szmch
  Bogura, Bogura, Bangladesh Recruiting
• Rahshahi medical college hospital
  Rajshahi, Rajshahi Division, Bangladesh Recruiting
• Chittagong Medical College Hospital
  Chittagong, Bangladesh Recruiting
• Dhaka Medical College Hospital
  Dhaka, Bangladesh Recruiting
• Mag Osmania Medical College Hospital Sylhet
  Sylhet, Bangladesh Recruiting
• Pgiemr
  Chandigarh, India Not yet recruiting

Study contacts

• Study coordinator: Prof Michael Eddleston, BA PhDScD FRCPEdin FEAPCCT
• Email: M.Eddleston@ed.ac.uk
• Phone: 0131 242 6776

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bicarbonate Levels in Hemodialysis Patients: A Look at Dialysis Details and Diet

  This observational study checks which factors influence bicarbonate in adults on maintenance dialysis to see how different dialysis practices and diet may affect metabolic balance.

  Recruiting East and North Hertfordshire NHS Trust · Stevenage, Hertfordshire · NCT07779200

• Sodium bicarbonate for critically ill patients with metabolic acidosis and AKI

  This trial tests whether giving sodium bicarbonate helps reduce major kidney problems 90 days later in adults with septic or critical illness and kidney injury.

  Recruiting Phase 4 Universität Münster · Münster · NCT07464431

• THAM vs. sodium bicarbonate for metabolic acidosis after cardiac surgery

  This trial tests whether THAM and sodium bicarbonate perform similarly to correct metabolic acidosis in patients having heart surgery with bypass.

  Recruiting Phase 4 Mayo Clinic · Rochester, Minnesota · NCT07424625

• Veverimer for metabolic acidosis in adults with chronic kidney disease.

  This 26-week trial will test whether veverimer can raise bicarbonate levels and improve outcomes in adults with moderate-to-severe CKD and metabolic acidosis.

  Recruiting at 27 sites Phase 3 Renibus Therapeutics, Inc. · Chula Vista, California and 27 other locations · NCT07355062

• Using a plant-based low protein diet to manage chronic kidney disease

  This study is testing if a plant-based low protein diet can help people with chronic kidney disease manage their condition better than a standard diet.

  Recruiting Lebanese American University · Beirut · NCT06932042

• Adding urea to the final dialysis fluid

  This test tries adding urea to the dialysis fluid for adults with advanced kidney failure who have very high blood urea and need rapid lowering of potassium or correction of severe acidosis.

  Recruiting Phase 1/2 University of California, San Francisco · San Francisco, California · NCT06366230

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.