Methanol PoisoningPhase 1iHV-MetNCT06173817
The Use of Isocapnic Hyperventilation (iHV) for Treatment of Methanol Poisoned Patients
A Phase 1 study testing isocapnic hyperventilation in people with Methanol Poisoning, run by Oslo University Hospital at 1 site in Iran.
Trial summary
The projects investigate if treatment with isocapnic hyperventilation can eliminate methanol from the body in a similar manner to dialysis. This is achieved by administering the antidote (fomepizole) and let the patient breathe on a isocapnic hyperventilation device while samples of blood, urine and maybe the breath… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Methanol Poisoning
- What is being tested?
- isocapnic hyperventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIran
- Study dates
- 29 Jan 2026to 29 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, men \& women diagnosed with methanol poisoning
- Serum-methanol ≥ 50 mg/dL (16 mM)
- pH ≥ 7.0, and correctable by bicarbonate infusion
- no (newly developed) visual disturbances
Who cannot join
- Acidosis requiring haemodialysis (pH <7.0), or acidosis that is not responding in spite of aggressive buffer (bicarbonate) treatment within maximum 1-2 hours.
- Comatose patients
- Newly developed visual disturbances
- ADH not fully blocked with antidotes, and not responding to additional dosing of fomepizole. Will be identified by a continuous or increasing anion gap (AG) or Base Excess (BE) on the blood gas machine.
Trial locations and contacts
1 site in 1 country.
About this study
The projects investigate if treatment with isocapnic hyperventilation can eliminate methanol from the body in a similar manner to dialysis. This is achieved by administering the antidote (fomepizole) and let the patient breathe on a isocapnic hyperventilation device while samples of blood, urine and maybe the breath are collected to measure the contents of methanol and its metabolites.
Read the detailed description
Isocapnic hyperventilation (iHV) The normal physiology breathing is a careful balance between the number of breaths per minute (rate/min) and the depth of each breath (tidal volume, Vt). Together they make up the minute ventilation (MV), where MV= rate x Vt). To maintain stable homeostasis in the organism, the minute ventilation is closely regulated to maintain adequate uptake of oxygen and adequate elimination of the carbon dioxide (CO2) that is produced by the metabolism. Too low minute ventilation leads to a buildup of CO2 and decrease in blood pH (respiratory acidosis), while hyperventilation (too high minute ventilation) leads to an excess loss of CO2 and increase in blood pH (respiratory alkalosis). The same mechanism will also enable the organism to compensate any metabolic disturbances (up to a certain point): A metabolic acidosis will be counteracted by a hyperventilation, whereas a metabolic alkalosis will be counteracted by a hypoventilation, both with the ultimate goal of keeping the acidity (as given by the pH) as closely regulated as possible.
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.
- Conditions
- Methanol Poisoning
- Being tested
- isocapnic hyperventilation
- Keywords
- isocapnic hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isocapnic hyperventilationDevice
isocapnic hyperventilation (iHV) increases the elimination of methanol to the extent that it could replace haemodialysis for elimination purposes when haemodialysis is not required for the correction of acidosis, and alcohol dehydrogenase (ADH) is completely blocked by an antidote.
| Study group | Role | What they receive |
|---|---|---|
| Isocapnic hyperventilation (iHV) | Experimental | Loading dose of fomepizole on clinical suspicion; A) History of intake of alcohol of unknown/illegal origin plus symptoms potentially occurring from methanol, or B) history as above and verified methanol poisonings among people drinking the same alcohol, or C) metabolic acidosis of unknown origin (where methanol cannot be excluded as the cause;or D) a combination of these.
● iHV started after a S-methanol concentration > 50 mg/dL is obtained (typically within 4 hours) and initial acidosis is partly or fully corrected by sodium bicarbonate (BD <15mM, HCO3- >10mM) Receives: Device: isocapnic hyperventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of methanol elimination kinetics, when iHV is utilized
T1/2 S-methanol (t1-t2) during iHV: Half-life of methanol in blood from start (t1) to end (t2) of treatment with iHV
T1/2 S-methanol (t0-t1) before iHV): Half-life of methanol in blood from t0 to t1 before start of treatment with iHV for evaluation of individual differences in kinetics
Measured: 0-40 hours
Secondary outcomes (11)
Characterization of methanol elimination kinetics, prior to iHV is utilized
T1/2 S-methanol (t0-t1) before iHV): Half-life of methanol in blood from t0 to t1 before start of treatment with iHV for evaluation of individual differences in kinetics
Measured: 0-40 hours
Serum formate kinetics
T1/2 S-formate before (t0-t1) before and after (t1-t2) (iHV): Half-life of formate in blood from t0 to t1 before start of treatment with iHV for evaluation of individual differences in kinetics
Measured: 0-40 hours
Elimination ratio of methanol
Evaluation of elimination ratio of methanol through breath vs. urine with or without iHV
Measured: 0-40 hours
Elimination ratio of formate
Evaluation of elimination ratio of formate through breath vs. urine with or without iHV
Measured: 0-40 hours
Feasibility of use of iHV in Iran
iHV is new in Iran. The process requires training to be implemented correctly. This will be evaluated by assessing protocol deviations related to iHV equipment and by interviewing study workers on their perceived competency using the iHV equipment.
This will not be reported in one value, but presented as text and used as an exploratory outcome to guide any future implementation of iHV in Iran
Measured: 0-40 hours
Tolerability by self reporting by patient
Patient tolerability of iHV as self reported by patient
This will be recorded using a five-level Likert Scale
1 Did not tolerate iHV at all 2: Tolerated iHV sin shorter periods, but below therapeutic level 3: Barely tolerated iHV enough for therapeutic level 4 Tolerate iHV enough for therapeutic level 5: No discomfort and good toleration of iHV
Measured: 0-40 hours
Implementation of fomepizole in Iran
Perception of simplicity of use of fomepizole amongst doctors involved in the study This will be recorded using a five-level Likert Scale
1 Fomepizole can not be used in the Iranian healthcare system 2: Fomepizole is difficult and require significant extra efforts to be used in the Iranian healthcare system 3: Fomepizole may be used the Iranian healthcare system with some extra effort 4 Fomepizole can easily be used the Iranian healthcare system with little extra effort 5: Fomepizole can easily be used the Iranian healthcare system with no extra effort
Measured: through study completion, estimated 2 years
Evaluation of fomepizole elimination during iHV
S-fomepizole analyzes from t1-t2. Pending availability of fomepizole analyzes
Measured: 0-4 hours
Length of ICU- and hospital stay
Length during treatment with iHV
Measured: from stdy start to death or discharge ICU, expected average 30 hours
Need for haemodialysis
Document type and degree of haemodialysis. Indication for such treatment is by the discretion of the local investigator. If S methanol >5mM after 26hrs (T1/2 50-80hrs during fomepizole treatment without haemodialysis (8)) or if patient becomes increasingly acidotic in spite of adequate antidote treatment.
Measured: 0- 40 hours
Adverse events
Adverse events, including death, will be defined according to Good Clinical Practice guidelines by the International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use. All adverse events will be registered in this trial and reported in accordance with local regulations in Iran.
Adverse events also include medical device deficiency of the isocapnic hyperventilation system
Measured: through study completion, estimated 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start29 Jan 2026
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Why it stopped: Difficulties in working across borders due to sanctions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methanol PoisoningStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm study * Enrolment target: 30 evaluable patients * Intervention: standard of care with sodium bicarbonate and fomepizole, plus iHV device treatment * Rescue therapy: haemodialysis at investigators discretion
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Loghman-Hakim Hospital, Teheran, Iran, Shohada-e-Tajrish Hospital, Teheran, Iran, Baharloo Hospital, Teheran, Iran, Imam Reza Hospital, Mashhad University of Medical Sciences, Iran, Khorshid Hospital, Isfahan University of Medical Sciences, Iran
- Responsible party
- Principal investigator, Knut Erik Hovda, MD, PhD, Oslo University Hospital
- Investigators
- Knut Erik Hovda, MD, Ph D, Principal investigator, The Norwegian CBRNE Centre, Department of Acute Medicine, Oslo University Hospital Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173817
- Sponsor's protocol ID
- iHV-Met_2.0
- Other IDs
- U1111-1277-6360, 475313, IRCT20120629010133N5
- Acronym
- iHV-Met
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2023
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification will be shared as Investigators discretion.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Isocapnic Hyperventilation (iHV) for Treatment of Methanol Poisoned Patients
- ClinicalTrials.gov ID
- NCT06173817
- Acronym / sponsor ID
- iHV-Met / iHV-Met_2.0
- Conditions
- Methanol Poisoning
- Keywords
- isocapnic hyperventilation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties in working across borders due to sanctions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Loghman-Hakim Hospital, Teheran, Iran, Shohada-e-Tajrish Hospital, Teheran, Iran, Baharloo Hospital, Teheran, Iran, Imam Reza Hospital, Mashhad University of Medical Sciences, Iran, Khorshid Hospital, Isfahan University of Medical Sciences, Iran
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 18 Dec 2023 (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.
The projects investigate if treatment with isocapnic hyperventilation can eliminate methanol from the body in a similar manner to dialysis. This is achieved by administering the antidote (fomepizole) and let the patient breathe on a isocapnic hyperventilation device while samples of blood, urine and maybe the breath are collected to measure the contents of methanol and its metabolites.
Detailed description
Isocapnic hyperventilation (iHV) The normal physiology breathing is a careful balance between the number of breaths per minute (rate/min) and the depth of each breath (tidal volume, Vt). Together they make up the minute ventilation (MV), where MV= rate x Vt). To maintain stable homeostasis in the organism, the minute ventilation is closely regulated to maintain adequate uptake of oxygen and adequate elimination of the carbon dioxide (CO2) that is produced by the metabolism. Too low minute ventilation leads to a buildup of CO2 and decrease in blood pH (respiratory acidosis), while hyperventilation (too high minute ventilation) leads to an excess loss of CO2 and increase in blood pH (respiratory alkalosis). The same mechanism will also enable the organism to compensate any metabolic disturbances (up to a certain point): A metabolic acidosis will be counteracted by a hyperventilation, whereas a metabolic alkalosis will be counteracted by a hypoventilation, both with the ultimate goal of keeping the acidity (as given by the pH) as closely regulated as possible.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm study * Enrolment target: 30 evaluable patients * Intervention: standard of care with sodium bicarbonate and fomepizole, plus iHV device treatment * Rescue therapy: haemodialysis at investigators discretion
| Arm | Type | Receives |
|---|---|---|
| Isocapnic hyperventilation (iHV) | Experimental | Device: isocapnic hyperventilationLoading dose of fomepizole on clinical suspicion; A) History of intake of alcohol of unknown/illegal origin plus symptoms potentially occurring from methanol, or B) history as above and verified methanol poisonings among people drinking the same alcohol, or C) metabolic acidosis of unknown origin (where methanol cannot be excluded as the cause;or D) a combination of these. ● iHV started after a S-methanol concentration > 50 mg/dL is obtained (typically within 4 hours) and initial acidosis is partly or fully corrected by sodium bicarbonate (BD <15mM, HCO3- >10mM) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, men \& women diagnosed with methanol poisoning
- Serum-methanol ≥ 50 mg/dL (16 mM)
- pH ≥ 7.0, and correctable by bicarbonate infusion
- no (newly developed) visual disturbances
Key exclusion criteria (4 listed)
- Acidosis requiring haemodialysis (pH <7.0), or acidosis that is not responding in spite of aggressive buffer (bicarbonate) treatment within maximum 1-2 hours.
- Comatose patients
- Newly developed visual disturbances
- ADH not fully blocked with antidotes, and not responding to additional dosing of fomepizole. Will be identified by a continuous or increasing anion gap (AG) or Base Excess (BE) on the blood gas machine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isocapnic hyperventilationisocapnic hyperventilation (iHV) increases the elimination of methanol to the extent that it could replace haemodialysis for elimination purposes when haemodialysis is not required for the correction of acidosis, and alcohol dehydrogenase (ADH) is completely blocked by an antidote. | Device | Isocapnic hyperventilation (iHV) |
Primary outcome
Characterization of methanol elimination kinetics, when iHV is utilized
Time frame: 0-40 hours
T1/2 S-methanol (t1-t2) during iHV: Half-life of methanol in blood from start (t1) to end (t2) of treatment with iHV T1/2 S-methanol (t0-t1) before iHV): Half-life of methanol in blood from t0 to t1 before start of treatment with iHV for evaluation of individual differences in kinetics
11 secondary outcomes
Characterization of methanol elimination kinetics, prior to iHV is utilized
Time frame: 0-40 hours
Serum formate kinetics
Time frame: 0-40 hours
Elimination ratio of methanol
Time frame: 0-40 hours
Elimination ratio of formate
Time frame: 0-40 hours
Feasibility of use of iHV in Iran
Time frame: 0-40 hours
Tolerability by self reporting by patient
Time frame: 0-40 hours
Implementation of fomepizole in Iran
Time frame: through study completion, estimated 2 years
Evaluation of fomepizole elimination during iHV
Time frame: 0-4 hours
Length of ICU- and hospital stay
Time frame: from stdy start to death or discharge ICU, expected average 30 hours
Need for haemodialysis
Time frame: 0- 40 hours
Adverse events
Time frame: through study completion, estimated 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification will be shared as Investigators discretion.
Related trials for Methanol Poisoning
RecruitingObservational study
A Study on Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning
Metabolic Acidosis
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. This study is not recruiting at the moment.
Knut Erik Hovda, MD, Ph D principal investigator
The Norwegian CBRNE Centre, Department of Acute Medicine, Oslo University Hospital Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing isocapnic hyperventilation in people with Methanol Poisoning, run by Oslo University Hospital at 1 site in Iran.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of methanol elimination kinetics, when iHV is utilized (time frame: 0-40 hours). 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 11 Feb 2026.