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

NCT ID: NCT06173817

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2026-06-30

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.

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

Keywords

isocapnic hyperventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Isocapnic hyperventilation (iHV)

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)

Group Type: EXPERIMENTAL

isocapnic hyperventilation

Intervention Type: 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.

Interventions

isocapnic hyperventilation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loghman-Hakim Hospital, Teheran, Iran

UNKNOWN

Sponsor Role: collaborator

Shohada-e-Tajrish Hospital, Teheran, Iran

UNKNOWN

Sponsor Role: collaborator

Baharloo Hospital, Teheran, Iran

UNKNOWN

Sponsor Role: collaborator

Imam Reza Hospital, Mashhad University of Medical Sciences, Iran

UNKNOWN

Sponsor Role: collaborator

Khorshid Hospital, Isfahan University of Medical Sciences, Iran

UNKNOWN

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Knut Erik Hovda, MD, PhD

Senior Consultant & Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Knut Erik Hovda, MD, Ph D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Loghman-Hakim Hospital,

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Knut Erik Hovda, MD, Ph D

Role: CONTACT

Phone: +4799618356

Email: knuterikhovda@gmail.com

Hossein Hassanian-Moghaddam, MD

Role: CONTACT

Email: hasanian2000@yahoo.com

Facility Contacts

Hossein Hassanian- Moghaddam, MD

Role: primary

Other Identifiers

U1111-1277-6360

Identifier Type: OTHER

Identifier Source: secondary_id

475313

Identifier Type: OTHER

Identifier Source: secondary_id

IRCT20120629010133N5

Identifier Type: REGISTRY

Identifier Source: secondary_id

iHV-Met_2.0

Identifier Type: -

Identifier Source: org_study_id