Health Condition 1: T511- Toxic effect of methanol
Conditions
Interventions
Intervention1: NA: NA
Intervention2: POC Formate assay: POC is Point of Care, The device measures formate in a semi-quantitative manner (negative, low positive, medium positive, high positive) for sim
Sponsors
The Queens Medical Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients presenting with suspected methanol poisoning or metabolic acidosis of unknown cause, including: a) Children aged 16 to 17 years, who are willing to provide assent. b) Parents or Guardians of children who are able and willing to provide consent. c) Adults (aged 18 years with no upper age limit) who are willing to provide informed consent. d) 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. 2) Methanol poisoning will be based on clinician judgement using the following typical indicators of possible methanol ingestion: a) History of: i) Intake of illegal/bootleg/spurious alcohol, and/or ii) other patients admitted with confirmed/suspected methanol poisoning and/or iii) Time from intake to symptoms more than 6-12 h b) Symptoms/clinical findings: i) Coma, and/or ii) Hyperventilation (respiratory rate, RR more than 20/min) and/or dyspnea, and/or iii) Visual disturbances (blurred vision, blindness), and/or iv) Gastrointestinal symptoms (vomiting, abdominal pain), and/or v) Chest pain, and/or vi) Severe/unusual hang-over: Feeling very sick the following day, and/or vii) Pseudo papillitis.
Exclusion criteria
Exclusion criteria: 1)Children aged 16-17 years, who are unwilling to provide assent. 2)Parents/Guardians of children who are unable or unwilling to provide consent. 3)Adults (aged 18 years with no upper age limit) who are unwilling to provide informed consent. 4)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) 5)Individuals previously recruited to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study 1a The sensitivity and specificity of POC formate test (index test) for diagnosis of methanol poisoning (target condition, as per the Gold standard laboratory formate assay) Study 1b Number of hospitals successfully recruited to studyTimepoint: Study 1a- 12 months Study 1b- 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Study 1a - 1.Time interval(in min) from patient’s arrival at emergency department until sample is drawn from patient 2.Time interval(in min) from when the sample is drawn to when the result is displayed by the POC assay 3.Time interval(in min) from when the sample is drawn to when the result is displayed to laboratory staff by the Gold standard assay 4.Delay between time of the Gold standard assay result being displayed & the time of the POC assay result being displayed 5.Time interval(in min) from when the sample is drawn until the clinician is informed about the result of the assays 6.Time interval(in min) to initiation of antidote treatment in patients with methanol toxicity from arrival at the emergency department 7.Time interval(in min) to stopping fomepizole inpatients who do not have methanol poisoning, after starting it and Use of unnecessary fomepizole therapy in patients who do not have methanol poisoningTimepoint: Study 1a- 12 months ;Study 1b- 1.Time (in min) to stopping fomepizole in patients who do not have methanol poisoning (after starting it) 2.Use of unnecessary fomepizole therapy in patients who do not have methanol poisoning 3. Proportion of patients with changed management (buffer,antidote, dialysis) based on the laboratory formate assay 4.Clinical outcomes (deaths, intubation, need for dialysis where available) 5.Cost of therapy of the POC formate assay vs. the LAB-assay vs. no assays.Timepoint: Study 1b- 24 months | — |
Countries
Bangladesh, India
Contacts
Public ContactDr Ashish Bhalla
PGIMER
Outcome results
None listed