- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01386788
European Survey: Risk of Cyanide Poisoning in Smoke Inhalation (RISK)
European Survey: Risk of Cyanide Poisoning in Smoke Inhalation, Symptoms, Key Treatment and Outcome (RISK)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Ludwigsburg, Germany, 71640
- Prof. Dr. Götz Geldner
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München, Germany, 81675
- Prof. Th. Zilker
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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
|
No intervention foreseen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival After 24 Hours
Time Frame: 24 hours
|
Number of participants who survived at 24 hours after smoke inhalation were reported.
|
24 hours
|
|
Serum Cyanide Levels
Time Frame: blood sampling within 2 hours after smoke inhalation
|
blood sampling within 2 hours after smoke inhalation
|
Collaborators and Investigators
Sponsor
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 and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EML015722-600
- 2009-010202-11 (Other Identifier: EudraCT No)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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