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Impact of Thermal Stress on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659410
Recruitment Status : Unknown
Verified January 2016 by Sami Haddad, Université de Montréal.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Collaborator:
Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
Information provided by (Responsible Party):
Sami Haddad, Université de Montréal

Brief Summary:
In Quebec, thousands of workers are concomitantly exposed to heat and chemical compounds. Exposure to heat induces physiological responses that help maintaining a stable body temperature. Those changes can affect organ functions implicated in absorption and metabolism. According to literature, those changes could lead to increased concentrations of chemical compounds in the body and their toxicity. Therefore, the aim of this study is to evaluate the pulmonary absorption and toxicokinetics of 3 organic solvents in heat stress conditions in volunteers exposed in a inhalation chamber. Results will then be used to develop PBPK models that will allow to predict organic solvent kinetics when coexposed with heat.

Condition or disease Intervention/treatment Phase
Heat Other: Heat stress (21) Other: Heat stress (25) Other: Heat stress (30) Other: Heat Stress (21) +TOL Other: Heat stress (25) + TOL Other: Heat stress (21) + TOL Other: Heat stress (21) + ACE Other: Heat stress (25) + ACE Other: Heat stress (30) + ACE Other: Heat stress (21) + DCM Other: Heat stress (25) + DCM Other: Heat stress (30) + DCM Other: Heat stress (21) + TOL (dermal) Other: Heat stress (25) + TOL (dermal) Other: Heat stress (30) + TOL (dermal) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Studying the Impact of Thermal Stress (Heat) Representative of Occupational Settings on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents
Study Start Date : November 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heat Illness

Arm Intervention/treatment
Experimental: Heat stress
4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.
Other: Heat stress (21)
4h exposure to heat (WBGT of 21°C), no solvent

Other: Heat stress (25)
4h exposure to heat (WBGT of 25°C), no solvent

Other: Heat stress (30)
4h exposure to heat (WBGT of 30°C), no solvent

Other: Heat Stress (21) +TOL
4h exposure to heat (WBGT of 21°C) + Toluene (concentration = TLV)

Other: Heat stress (25) + TOL
4h exposure to heat (WBGT of 25°C) + Toluene (concentration = TLV)

Other: Heat stress (21) + TOL
4h exposure to heat (WBGT of 30°C) + Toluene (concentration = TLV)

Other: Heat stress (21) + ACE
4h exposure to heat (WBGT of 21°C) + Acetone (concentration = TLV)

Other: Heat stress (25) + ACE
4h exposure to heat (WBGT of 25°C) + Acetone (concentration = TLV)

Other: Heat stress (30) + ACE
4h exposure to heat (WBGT of 30°C) + Acetone (concentration = TLV)

Other: Heat stress (21) + DCM
4h exposure to heat (WBGT of 21°C) + Dichloromethane (concentration = TLV)

Other: Heat stress (25) + DCM
4h exposure to heat (WBGT of 25°C) + Dichloromethane (concentration = TLV)

Other: Heat stress (30) + DCM
4h exposure to heat (WBGT of 30°C) + Dichloromethane (concentration = TLV)

Other: Heat stress (21) + TOL (dermal)
4h exposure to heat (WBGT of 21°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.

Other: Heat stress (25) + TOL (dermal)
4h exposure to heat (WBGT of 25°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.

Other: Heat stress (30) + TOL (dermal)
4h exposure to heat (WBGT of 30°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.




Primary Outcome Measures :
  1. Respiratory rate [ Time Frame: 4hour ]
    Respiratory rate will be monitored continuously for 4hour with a respirometer

  2. Cardiac frequency [ Time Frame: 4hour ]
    Cardiac frequency will be monitored continuously for 4hour with a respirometer

  3. Minute ventilation [ Time Frame: 4hour ]
    Minute ventilation will be monitored continuously for 4hour with a respirometer

  4. Tidal volume [ Time Frame: 4hour ]
    Tidal volume will be monitored continuously for 4hour with a respirometer

  5. Solvent in blood [ Time Frame: 4,5hour ]
    Solvents concentrations will be measured in blood samples collected at different times (t=0, 2, 4 and 4.5hour).

  6. Solvent or metabolite in urine [ Time Frame: 18hour ]
    Solvent or metabolite concentrations (o-cresol for toluene exposures) will be measured for urine samples collected at different times (t=0, 4, 10 and 18hour).

  7. Solvent in exhaled air [ Time Frame: 6hour ]
    Solvents concentrations will be measured in exhaled air samples collected at different times (t=0, 1.5, 3, 4.5 and 6hour).


Secondary Outcome Measures :
  1. Oxygen consumption [ Time Frame: 4hour ]
    oxygen consumption will be monitored continuously for 4hour with a respirometer

  2. Carbonic dioxide production [ Time Frame: 4hour ]
    carbonic dioxide production will be monitored continuously for 4hour with a respirometer

  3. Body temperature [ Time Frame: 4hour ]
    Body temperature is monitored continuously by telemetry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index between 18,5 et 25 kg/m3

Exclusion Criteria:

  • Smoking
  • Respiratory, cardiovascular and neurological problems
  • History of exposure to solvents
  • Chronic medication
  • Abusive and/or chronic alcohol consumption
  • Alcohol consumption 24h before or 18h following exposure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659410


Contacts
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Contact: Sami Haddad, Ph.D 514-343-6111 ext 38166 sami.haddad@umontreal.ca

Locations
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Canada, Quebec
Université de Montréal Recruiting
Montreal, Quebec, Canada, H3T 1J4
Contact: Sami Haddad, Ph.D    514-343-6111 ext 36188    sami.haddad@umontreal.ca   
Principal Investigator: Sami Haddad, PhD         
Sub-Investigator: Axelle Marchand, M.Sc         
Sub-Investigator: Pierre Brochu, PhD         
Sub-Investigator: Ginette Truchon, PhD         
Sub-Investigator: Jessie Ménard, M.Sc         
Sponsors and Collaborators
Université de Montréal
Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
Investigators
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Study Director: Sami Haddad, Ph.D Université de Montréal
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Responsible Party: Sami Haddad, Professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT02659410    
Other Study ID Numbers: 14-140-CERES-P
2013-0012 ( Other Grant/Funding Number: IRSST )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Sami Haddad, Université de Montréal:
Physiologically based pharmacokinetic modeling
Organic solvents