The Use of Isocapnic Hyperventilation (iHV) for Treatment of Methanol Poisoned Patients

NCT06173817 | Withdrawn Phase 1 DMC

• 4 other identifiers: iHV-Met_2.0U1111-1277-6360475313IRCT20120629010133N5
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 are collected to measure the contents of methanol and its metabolites.

Conditions

Methanol Poisoning

Keywords

isocapnic hyperventilation

Outcome Measures

Primary Outcomes (1)

• 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

  0-40 hours

Secondary Outcomes (11)

• Characterization of methanol elimination kinetics, prior to iHV is utilized

  0-40 hours

• Serum formate kinetics

  0-40 hours

• Elimination ratio of methanol

  0-40 hours

• Elimination ratio of formate

  0-40 hours

• Feasibility of use of iHV in Iran

  0-40 hours

Study Arms (1)

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)

Device: isocapnic hyperventilation

Interventions

isocapnic hyperventilation DEVICE

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.

Isocapnic hyperventilation (iHV)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Loghman-Hakim Hospital, Teheran, Iran: collaborator
• Shohada-e-Tajrish Hospital, Teheran, Iran: collaborator
• Baharloo Hospital, Teheran, Iran: collaborator
• Imam Reza Hospital, Mashhad University of Medical Sciences, Iran: collaborator
• Khorshid Hospital, Isfahan University of Medical Sciences, Iran: collaborator

Study Sites (1)

Loghman-Hakim Hospital,

Tehran, Iran

Location

Study Officials

• Knut Erik Hovda, MD, Ph D

  The Norwegian CBRNE Centre, Department of Acute Medicine, Oslo University Hospital Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant & Professor

Model Details: 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

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 18, 2023
• Study Start: January 29, 2026
• Primary Completion: January 29, 2026
• Study Completion: January 29, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication

Locations

IR (1)