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European Survey: Risk of Cyanide Poisoning in Smoke Inhalation (RISK)

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ClinicalTrials.gov Identifier: NCT01386788
Recruitment Status : Completed
First Posted : July 1, 2011
Results First Posted : September 28, 2016
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Ernst MW Koch

Brief Summary:

Cyanide poisoning is commonly viewed as a rare but dramatic event, occurring in industrial or laboratory settings as the result of accidental releases of hydrogen cyanide (HCN) gas (e.g. in the case of fire) or salts in the case of suicide attempts.

In fact, cyanide poisoning is considerably more common than is generally appreciated. Multiple clinical and post-mortal studies have demonstrated that HCN contributes to the toxicity of fire smoke.

Cyanide acts primarily through its strong affinity for the iron-containing heme moiety, binding to numerous critical enzyme systems in the body and rendering them inactive. Of late, increasing attention has been paid to the relationship of cyanide and nitric oxide. The interactions appear to be complex, with cyanide inducing nitric oxide production by binding to N-methyl-D-aspartate (NMDA) receptors, as well as binding to nitric oxide synthase. The latter may be overcome by the presence of nitric oxide synthase inhibitors.

Probably, the majority of the cyanide poisoning cases are due to smoke inhalation in closed-space fires.

So far, there are no clear data available on the prevalence of cyanide poisoning in smoke inhalation.

This information would be of great interest for all emergency physicians since a proven or supposed cyanide poisoning does not only requires an intensive supportive care, including the administration of supplemental oxygen and artificial ventilation, blood pressure support, and anticonvulsants, but also a rapid administration of a cyanide antidote.

Therefore, it is the goal of this survey to assess the prevalence of cyanide poisoning in smoke inhalation victims. Only the data of patients with a cyanide measurement before specific antidote treatment will be included


Condition or disease Intervention/treatment
Smoke Inhalation Patients Other: There is no intervention planned (observational)

Detailed Description:

Cyanide poisoning is commonly viewed as a rare but dramatic event, occurring in industrial or laboratory settings as the result of accidental releases of hydrogen cyanide (HCN) gas (e.g. in the case of fire) or salts in the case of suicide attempts.

In fact, cyanide poisoning is considerably more common than is generally appreciated. Multiple clinical [1-4] and post-mortal studies [5-10] have demonstrated that HCN contributes to the toxicity of fire smoke.

Cyanide acts primarily through its strong affinity for the iron-containing heme moiety, binding to numerous critical enzyme systems in the body and rendering them inactive [11]. Of late, increasing attention has been paid to the relationship of cyanide and nitric oxide. The interactions appear to be complex, with cyanide inducing nitric oxide production by binding to N-methyl-D-aspartate (NMDA) receptors [12], as well as binding to nitric oxide synthase. The latter may be overcome by the presence of nitric oxide synthase inhibitors.

Probably, the majority of the cyanide poisoning cases are due to smoke inhalation in closed-space fires.

So far, there are no clear data available on the prevalence of cyanide poisoning in smoke inhalation.

This information would be of great interest for all emergency physicians since a proven or supposed cyanide poisoning does not only requires an intensive supportive care, including the administration of supplemental oxygen and artificial ventilation, blood pressure support, and anticonvulsants, but also a rapid administration of a cyanide antidote.

Therefore, it is the goal of this survey to assess the prevalence of cyanide poisoning in smoke inhalation victims. Only the data of patients with a cyanide measurement before specific antidote treatment will be included.


Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Survey: Risk of Cyanide Poisoning in Smoke Inhalation, Symptoms, Key Treatment and Outcome (RISK)
Study Start Date : April 2009
Primary Completion Date : June 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning
U.S. FDA Resources

Group/Cohort Intervention/treatment
Smoke Inhalation patients
Closed space fire, Soot deposits, Altered mental status Blood specimen before intravenous antidote treatment (cyanide measurement) Known delay between end of smoke exposure and blood sampling
Other: There is no intervention planned (observational)
No intervention foreseen



Primary Outcome Measures :
  1. Overall Survival After 24 Hours [ Time Frame: 24 hours ]
    Number of participants who survived at 24 hours after smoke inhalation were reported.

  2. Serum Cyanide Levels [ Time Frame: blood sampling within 2 hours after smoke inhalation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with smoke inhalation
Criteria

Inclusion Criteria:

  • Closed space fire, Soot deposits, Altered mental status
  • Blood specimen before intravenous antidote treatment (cyanide measurement)
  • Known delay between end of smoke exposure and blood sampling
  • Malaise and/or Headache and/or Altered mental status in fire workers

Exclusion Criteria:

  • Pregnancy
  • Multiple trauma, Blast
  • Patient pronounced dead at scene without resuscitation attempt
  • Patient in whom the time elapsed between the end of exposure and blood sampling is greater than 2 hours

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): NCT01386788


Locations
Germany
Prof. Dr. Götz Geldner
Ludwigsburg, Germany, 71640
Prof. Th. Zilker
München, Germany, 81675
Sponsors and Collaborators
Dr. Ernst MW Koch
Investigators
Study Chair: Thomas Zilker, Prof. TU München
Study Chair: Carlo A Locatelli, Prof IRCCS Fondazione Maugeri
Study Chair: Frédéric Baud, Prof Hôpital Lariboisière
Study Chair: Guillermo Burillo-Putze, Prof Universidad de Teneriffe
Study Chair: Jean-Philippe Fauville, Dr To be added
Study Chair: Francois Levy, Dr To be added

Publications:
Responsible Party: Dr. Ernst MW Koch, Dr
ClinicalTrials.gov Identifier: NCT01386788     History of Changes
Other Study ID Numbers: EML015722-600
2009-010202-11 ( Other Identifier: EudraCT No )
First Posted: July 1, 2011    Key Record Dates
Results First Posted: September 28, 2016
Last Update Posted: September 28, 2016
Last Verified: August 2016

Keywords provided by Dr. Ernst MW Koch:
Smoke, cyanide, closed space fires

Additional relevant MeSH terms:
Respiratory Aspiration
Poisoning
Smoke Inhalation Injury
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Chemically-Induced Disorders
Burns, Inhalation
Burns
Wounds and Injuries