Metabolic AcidosisNCT06881641
A Study on Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning
An observational study of Metabolic Acidosis, run by University of Edinburgh at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Metabolic Acidosis
- How many people
- 6,120 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 22 Jun 2025to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include patients presenting to large referral hospitals in 2 countries (Bangladesh, India) with suspicion of methanol poisoning or unexplained metabolic acidosis.
Who may be able to join
- 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:
Show all 21Show fewer
- 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.
Who cannot join
- • 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Michael Eddleston contact
6 sites in 2 countries
Bangladesh5 sites, 5 recruiting
- Recruiting
SZMCH
Bogura, Bogura, 5800
MD HALIMUR RASHID, rashidhalimur@yahoo.com
MD HALIMUR RASHID
- Recruiting
Chittagong Medical College Hospital
Chittagong
PROF ANIRUDDHA GHOSH
ANIRUDDHA GHOSH
- Recruiting
Dhaka Medical College Hospital
Dhaka, 1205
Prof Shafiqul Bari
- Recruiting
Rahshahi medical college hospital
Rajshahi, Rajshahi Division, 6000
Dr Abu Shahin
- Recruiting
Mag Osmania Medical College Hospital Sylhet
Sylhet
PROF SHISHIR CHAKRABORTY
PROF SHISHIR CHAKRABORTY
India1 site, 1 recruiting
- Not yet recruiting
PGIEMR
Chandigarh
PROF ASHISH BHALLA, v1abhall@exseed.ed.ac.uk
PROF ASHISH BHALLA
About this study
Official title: Sensitivity, Specificity, and Acceptability of a Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning: Prospective Observational and Randomized Studies
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.
Read more
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.
Read the 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 measures formate, present only in cases of methanol poisoning.
The research comprises two studies. The initial observational study (Study 1a) will assess the sensitivity and specificity of the POC formate assay compared to the laboratory formate assay (the gold standard). If the sensitivity is greater than 0.80, a feasibility three-arm cluster randomized controlled trial (RCT) (Study 1b) will follow to determine the feasibility of recruiting hospitals to a cluster RCT of formate diagnostic approaches.
This design will be used in the second study to test the clinical- and cost-effectiveness of incorporating the formate POC assay into routine clinical use.
Primary Objectives:
Study 1a: Determine the sensitivity and specificity of the POC formate assay compared to the laboratory formate assay.
Study 1b: Assess the feasibility of recruiting hospitals for a cluster RCT of formate diagnostic approaches.
Secondary Objectives:
Study 1a: Evaluate the use of the POC formate assay to identify methanol poisoning across diverse healthcare systems.
Study 1b: Compare clinical and resource use when introducing the POC formate assay into routine clinical practice.
Primary Endpoints:
Study 1a: Sensitivity and specificity of the POC formate test for diagnosing methanol poisoning.
Study 1b: Number of hospitals successfully recruited to the study.
Secondary Endpoints for Study 1a:
Time from patient arrival at the emergency department to sample collection.
Time from sample collection to result display by the POC assay and the laboratory assay.
Delay between result displays by the POC and the laboratory assay.
Time from sample collection until the clinician is informed of the results.
Time to initiation of antidote treatment and stopping unnecessary therapy in patients without methanol poisoning.
Secondary Endpoints for Study 1b:
Time to stopping unnecessary therapy in patients without methanol poisoning.
Proportion of patients with management changes based on the laboratory formate assay.
Clinical outcomes such as deaths, intubations, and dialysis needs.
Cost comparison between the POC formate assay, the laboratory assay, and no assay.
The study will include patients suspected of methanol poisoning or unexplained metabolic acidosis at large referral hospitals in Bangladesh and India. The study aims to determine whether the POC formate test can speed up the initiation of appropriate treatment, reduce unnecessary treatment costs, and improve clinical outcomes.
Study Population:
Patients presenting with suspected methanol poisoning or unexplained metabolic acidosis.
Number of Participants:
Study 1a: 1,620 participants.
Study 1b: 4,500 participants.
Inclusion Criteria:
Patients with suspected methanol poisoning or metabolic acidosis of unknown cause, including children aged 16-17 (with assent), adults (with consent), and those with relatives who can provide consent.
Exclusion Criteria:
Individuals unwilling to provide assent or consent.
Unaccompanied unconscious patients or those without a relative to provide consent.
Previously recruited individuals.
These studies aim to raise awareness of the methanol poisoning crisis, improve early detection and treatment, and establish high-quality protocols for patient care. They also aim to encourage junior doctors to pursue academic careers and practice good clinical habits. Raising awareness will help warn the public about dangerous alcohol and prevent further poisonings.
- Conditions
- Metabolic Acidosis
- Keywords
- methanol toxicity
- Medical subject headings
- Acidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective 1
To determine the sensitivity and specificity of the POC formate assay compared to the laboratory formate assay.
Measured: Day1
Primary objective 2
Evaluate the use of the POC formate assay for methanol poisoning. Compare clinical and resource use of using the POC formate assay by introducing the assay into routine clinical use.
Measured: Day1
Secondary outcomes (1)
Secondary objective
Time interval (in minutes) from the patient's arrival at the emergency department until the sample is drawn from the patient.
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start22 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Michael Eddleston, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881641
- Sponsor's protocol ID
- AC23008
- Other IDs
- NIHR203140
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity, Specificity, and Acceptability of a Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning: Prospective Observational and Randomized Studies
- ClinicalTrials.gov ID
- NCT06881641
- Acronym / sponsor ID
- AC23008
- Conditions
- Metabolic Acidosis
- Keywords
- methanol toxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,120 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 22 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 measures formate, present only in cases of methanol poisoning.
The research comprises two studies. The initial observational study (Study 1a) will assess the sensitivity and specificity of the POC formate assay compared to the laboratory formate assay (the gold standard). If the sensitivity is greater than 0.80, a feasibility three-arm cluster randomized controlled trial (RCT) (Study 1b) will follow to determine the feasibility of recruiting hospitals to a cluster RCT of formate diagnostic approaches.
This design will be used in the second study to test the clinical- and cost-effectiveness of incorporating the formate POC assay into routine clinical use.
Primary Objectives:
Study 1a: Determine the sensitivity and specificity of the POC formate assay compared to the laboratory formate assay.
Study 1b: Assess the feasibility of recruiting hospitals for a cluster RCT of formate diagnostic approaches.
Secondary Objectives:
Study 1a: Evaluate the use of the POC formate assay to identify methanol poisoning across diverse healthcare systems.
Study 1b: Compare clinical and resource use when introducing the POC formate assay into routine clinical practice.
Primary Endpoints:
Study 1a: Sensitivity and specificity of the POC formate test for diagnosing methanol poisoning.
Study 1b: Number of hospitals successfully recruited to the study.
Secondary Endpoints for Study 1a:
Time from patient arrival at the emergency department to sample collection.
Time from sample collection to result display by the POC assay and the laboratory assay.
Delay between result displays by the POC and the laboratory assay.
Time from sample collection until the clinician is informed of the results.
Time to initiation of antidote treatment and stopping unnecessary therapy in patients without methanol poisoning.
Secondary Endpoints for Study 1b:
Time to stopping unnecessary therapy in patients without methanol poisoning.
Proportion of patients with management changes based on the laboratory formate assay.
Clinical outcomes such as deaths, intubations, and dialysis needs.
Cost comparison between the POC formate assay, the laboratory assay, and no assay.
The study will include patients suspected of methanol poisoning or unexplained metabolic acidosis at large referral hospitals in Bangladesh and India. The study aims to determine whether the POC formate test can speed up the initiation of appropriate treatment, reduce unnecessary treatment costs, and improve clinical outcomes.
Study Population:
Patients presenting with suspected methanol poisoning or unexplained metabolic acidosis.
Number of Participants:
Study 1a: 1,620 participants.
Study 1b: 4,500 participants.
Inclusion Criteria:
Patients with suspected methanol poisoning or metabolic acidosis of unknown cause, including children aged 16-17 (with assent), adults (with consent), and those with relatives who can provide consent.
Exclusion Criteria:
Individuals unwilling to provide assent or consent.
Unaccompanied unconscious patients or those without a relative to provide consent.
Previously recruited individuals.
These studies aim to raise awareness of the methanol poisoning crisis, improve early detection and treatment, and establish high-quality protocols for patient care. They also aim to encourage junior doctors to pursue academic careers and practice good clinical habits. Raising awareness will help warn the public about dangerous alcohol and prevent further poisonings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include patients presenting to large referral hospitals in 2 countries (Bangladesh, India) with suspicion of methanol poisoning or unexplained metabolic acidosis.
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (5 listed)
- • Children aged 16-17 years, who are unwilling to provide assent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary objective 1
Time frame: Day1
To determine the sensitivity and specificity of the POC formate assay compared to the laboratory formate assay.
Primary objective 2
Time frame: Day1
Evaluate the use of the POC formate assay for methanol poisoning. Compare clinical and resource use of using the POC formate assay by introducing the assay into routine clinical use.
1 secondary outcome
Secondary objective
Time frame: Day1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Eddleston contact
Prof Michael Eddleston study chair
University of Edinburgh
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Acidosis, run by University of Edinburgh at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Bangladesh, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof Michael Eddleston, BA PhDScD FRCPEdin FEAPCCT (0131 242 6776, M.Eddleston@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective 1 (time frame: Day1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.