Protocol summary
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Study aim
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Our main goal is to evaluate methanol kinetics (and formate kinetics) during iHV when toxicity is being prevented by fomepizole blockade of ADH.
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Design
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This prospective (phase I) study, will be conducted on 30 methanol-poisoned patients referring to the toxicological emergency department of Loghman Hakim hospital in 2022.
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Settings and conduct
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Setting: Loghman Hakim Hospital
Intervention: Standard of care with Fomepizole plus iHV device treatment
Rescue therapy: Haemodialysis at investigator's discretion
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Participants/Inclusion and exclusion criteria
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Inclusion:
Adult patients, men & women diagnosed with methanol poisoning
S-metOH ≥ 50mg/dL
pH ≥ 7.0, correctable by bicarbonate infusion
no visual disturbances
Exclusion:
Acidosis requiring haemodialysis
Comatose patients
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Intervention groups
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Methanol toxicity patients who have a serum methanol level ≥ 50mg/dL
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Main outcome variables
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Definition of methanol and formate elimination kinetics, including physiologically based pharmacokinetic (PBPK) modeling, when iHV is utilized
General information
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Reason for update
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Acronym
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iHV
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IRCT registration information
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IRCT registration number:
IRCT20120629010133N5
Registration date:
2022-09-10, 1401/06/19
Registration timing:
prospective
Last update:
2023-12-03, 1402/09/12
Update count:
1
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Registration date
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2022-09-10, 1401/06/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-10-23, 1401/08/01
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Expected recruitment end date
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2023-12-22, 1402/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Isocapnic hyperventilation (iHV) on detoxification of methanol poisoned patients: A pilot study
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Public title
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The effect of increasing pulmonary ventilation in methanol poisoning
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Adult patients, men & women diagnosed with methanol poisoning
Serum methanol ≥ 50mg/dL
pH ≥ 7.0, correctable by bicarbonate infusion
no visual disturbances
Exclusion criteria:
Acidosis requiring haemodialysis
Comatose patients
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Age
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From 18 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
14
Arterial blood gas, Serum Methanol Level, Serum Formate Level
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-07-24, 1401/05/02
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1401.214
Health conditions studied
1
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Description of health condition studied
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Toxic alcohols
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ICD-10 code
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T51.1
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ICD-10 code description
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Toxic effect of methanol
Primary outcomes
1
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Description
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Change in methanol elimination kinetics (half-life and estimated clearance) when iHV is utilized
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Timepoint
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Hourly before intervention, and 1-2 hourly post intervention till 24 hours
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Method of measurement
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Measuring serum/urine methanol, formate
Secondary outcomes
1
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Description
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Score of iHV machine tolerability
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Timepoint
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Hourly
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Method of measurement
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Qualitative interview
2
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Description
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Score of feasibility of iHV machine
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Timepoint
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Hourly
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Method of measurement
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Likert's scale
3
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Description
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Implementation of fomepizole in Iran
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Timepoint
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End of trial
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Method of measurement
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Likert's scale
4
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Description
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Length of ICU- and hospital stay during treatment with iHV
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Timepoint
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End of trial
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Method of measurement
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Time frame of hospital stay
5
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Description
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Death
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Timepoint
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End of trial
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Method of measurement
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Yes or No
6
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Description
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Need for haemodialysis
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Timepoint
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hourly
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Method of measurement
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Yes or No
7
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Description
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Adverse Events
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Timepoint
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hourly
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Method of measurement
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Yes or No
Intervention groups
1
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Description
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Intervention group: iHV. The concept of isocapnic hyperventilation (iHV) allows the person to hyperventilate while keeping the CO2 within normal limits at the same time. The ClearMate (Thornhill Research Inc., Canada) adds CO2 to the inspired air to compensate to the increased loss induced by the increased minute ventilation. This means that hyperventilation can occur, and a wash-out of volatile substances such as methanol will happen without disrupting the important CO2 balance. iHV increases the elimination of methanol to the extent that it could replace hemodialysis for elimination purposes when hemodialysis is not required for the correction of acidosis. Likewise, Alcohol Dehydrogenase (ADH), the responsible enzyme for methanol metabolization and further acidosis is completely blocked by Fomepizole during the intervention. Methanol serum level will be measured every 2 hours and iHV will be stopped if it is <5 mmol.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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The iHV-Met study
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Grant code / Reference number
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32499
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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University in Oslo
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Proportion provided by this source
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95
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Public or private sector
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Public
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Domestic or foreign origin
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Foreign
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Category of foreign source of funding
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Sponsor: country of origin
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Country of origin
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NO
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Only main outcomes will be shared
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When the data will become available and for how long
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Sharing at the time of publication in a scientific journal
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To whom data/document is available
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Only for researchrs
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Under which criteria data/document could be used
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It would be defined later
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From where data/document is obtainable
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Via email
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What processes are involved for a request to access data/document
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Having a reasonable request, it takes almost one month
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Comments
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No