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Recruitment centers
#1
Name of recruitment center - English: Loghman-Hakim Hospital-Tehran
Name of recruitment center - Persian: بیمارستان لقمان حکیم-تهران
Full name of responsible person - English: Hossein Hassanian-Moghaddam
Full name of responsible person - Persian: حسین حسنیان مقدم
Street address - English: Loghman-Hakim Hospital, Kamali Ave, South Karegar St
Street address - Persian: خ کارگر جنوبی، خ کمالی، بیمارستان لقمان حکیم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 13336
Phone: +98 21 5540 9534
Fax:
Email: hassanian@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Shohada-e Tajrish Hospital-Tehran
Name of recruitment center - Persian: بیمارستان شهدای تجریش-تهران
Full name of responsible person - English: Hossein Hassanian-Moghaddam
Full name of responsible person - Persian: حسین حسنیان مقدم
Street address - English: Shahada-e Tajrish Hospital, Shahrdari St
Street address - Persian: تجریش، خ شهرداری، بیمارستان شهدای تجریش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 19899 34148
Phone: +98 21 25719
Fax:
Email: hassanian@sbmu.ac.ir
Web page address:
Name of recruitment center - English: LoghmanShohada-Hakime Tajrish Hospital-Tehran Name of recruitment center - Persian: بیمارستان لقمان حکیمشهدای تجریش-تهران Full name of responsible person - English: Hossein Hassanian-Moghaddam Full name of responsible person - Persian: حسین حسنیان مقدم Street address - English: LoghmanShahada-Hakime Tajrish Hospital, Kamali Ave, South KaregarShahrdari St Street address - Persian: خ کارگر جنوبیتجریش، خ کمالیشهرداری، بیمارستان لقمان حکیمشهدای تجریش City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1333619899 34148 Phone: +98 21 5540 953425719 Fax: Email: hassanian@sbmu.ac.ir Web page address:
#2
Name of recruitment center - English: Baharlou Hospital
Name of recruitment center - Persian: بیمارستان بهار لو
Full name of responsible person - English: Behnam Behnoush
Full name of responsible person - Persian: بهنام بهنوش
Street address - English: Rahahan St, Anbar Naft St، Behdari st
Street address - Persian: میدان راه آهن، خ انبار نفت، خ بهداری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 13399 73111
Phone: +98 21 5565 8500
Fax:
Email: behnam.behnoush@gmail.com
Web page address:
Name of recruitment center - English: Baharlou Hospital Name of recruitment center - Persian: بیمارستان بهار لو Full name of responsible person - English: Behnam Behnoush Full name of responsible person - Persian: بهنام بهنوش Street address - English: Rahahan St, Anbar Naft St، Behdari st Street address - Persian: میدان راه آهن، خ انبار نفت، خ بهداری City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 13399 73111 Phone: +98 21 5565 8500 Fax: Email: behnam.behnoush@gmail.com Web page address:
Protocol summary
Study aim
Our main goal is to evaluate methanol kinetics (and formate kinetics) during iHV when toxicity is being prevented by fomepizole blockade of ADH.
Design
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.
Settings and conduct
Setting: Loghman Hakim Hospital
Intervention: Standard of care with Fomepizole plus iHV device treatment
Rescue therapy: Haemodialysis at investigator's discretion
Participants/Inclusion and exclusion criteria
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
Intervention groups
Methanol toxicity patients who have a serum methanol level ≥ 50mg/dL
Main outcome variables
Definition of methanol and formate elimination kinetics, including physiologically based pharmacokinetic (PBPK) modeling, when iHV is utilized
General information
Reason for update
Acronym
iHV
IRCT registration information
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
Registration date
2022-09-10, 1401/06/19
Registrant information
Name
Hossein Hassanian-Moghaddam
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4041
Email address
hassanian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Isocapnic hyperventilation (iHV) on detoxification of methanol poisoned patients: A pilot study
Public title
The effect of increasing pulmonary ventilation in methanol poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients, men & women diagnosed with methanol poisoning
Serum methanol ≥ 50mg/dL
pH ≥ 7.0, correctable by bicarbonate infusion
no visual disturbances
Change in methanol elimination kinetics (half-life and estimated clearance) when iHV is utilized
Timepoint
Hourly before intervention, and 1-2 hourly post intervention till 24 hours
Method of measurement
Measuring serum/urine methanol, formate
Secondary outcomes
1
Description
Score of iHV machine tolerability
Timepoint
Hourly
Method of measurement
Qualitative interview
2
Description
Score of feasibility of iHV machine
Timepoint
Hourly
Method of measurement
Likert's scale
3
Description
Implementation of fomepizole in Iran
Timepoint
End of trial
Method of measurement
Likert's scale
4
Description
Length of ICU- and hospital stay during treatment with iHV
Timepoint
End of trial
Method of measurement
Time frame of hospital stay
5
Description
Death
Timepoint
End of trial
Method of measurement
Yes or No
6
Description
Need for haemodialysis
Timepoint
hourly
Method of measurement
Yes or No
7
Description
Adverse Events
Timepoint
hourly
Method of measurement
Yes or No
Intervention groups
1
Description
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.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-e Tajrish Hospital-Tehran
Full name of responsible person
Hossein Hassanian-Moghaddam
Street address
Shahada-e Tajrish Hospital, Shahrdari St
City
Tehran
Province
Tehran
Postal code
19899 34148
Phone
+98 21 25719
Email
hassanian@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Baharlou Hospital
Full name of responsible person
Behnam Behnoush
Street address
Rahahan St, Anbar Naft St، Behdari st
City
Tehran
Province
Tehran
Postal code
13399 73111
Phone
+98 21 5565 8500
Email
behnam.behnoush@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Hassanian-Moghaddam
Street address
loghman-Hakim Hospital, Kamali Ave, South Karegar St
City
Tehran
Province
Tehran
Postal code
13336
Phone
+98 21 5540 9534
Email
hassanian@sbmu.ac.ir
Grant name
The iHV-Met study
Grant code / Reference number
32499
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University in Oslo
Proportion provided by this source
95
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
NO
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hosssein Hassanian-Moghaddam
Position
Assiciate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Loghman-Hakim Hospital, Kamali Ave, South Karegar
City
Tehran
Province
Tehran
Postal code
13336
Phone
+98 21 5540 9534
Email
hassanian@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Hassanian-Moghaddam
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
No 9, Hedyeh Alley, Opposite to Hosseinyeh Ershad, Shariati St
City
Tehran
Province
Tehran
Postal code
1546817613
Phone
+98 21 2222 0980
Email
hasanian2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hosein Hassanian-Moghaddam
Position
Research and Educational deputy of Clinical Toxicology Department
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Loghamn-Hakim Hospital, Kamali Ave, South Karegar
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5540 9534
Fax
+98 21 5540 9534
Email
hassanian@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only main outcomes will be shared
When the data will become available and for how long
Sharing at the time of publication in a scientific journal
To whom data/document is available
Only for researchrs
Under which criteria data/document could be used
It would be defined later
From where data/document is obtainable
Via email
What processes are involved for a request to access data/document
Having a reasonable request, it takes almost one month