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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Ernst MW Koch
ClinicalTrials.gov Identifier:
NCT01386788
First received: June 27, 2011
Last updated: August 5, 2016
Last verified: August 2016
  Purpose

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 Intervention
Smoke Inhalation Patients
Other: There is no intervention planned (observational)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Survey: Risk of Cyanide Poisoning in Smoke Inhalation, Symptoms, Key Treatment and Outcome (RISK)

Resource links provided by NLM:


Further study details as provided by Dr. Ernst MW Koch:

Primary Outcome Measures:
  • Overall Survival After 24 Hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Number of participants who survived at 24 hours after smoke inhalation were reported.

  • Serum Cyanide Levels [ Time Frame: blood sampling within 2 hours after smoke inhalation ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Dr. Ernst MW Koch, Dr
ClinicalTrials.gov Identifier: NCT01386788     History of Changes
Other Study ID Numbers: EML015722-600  2009-010202-11 
Study First Received: June 27, 2011
Results First Received: September 13, 2013
Last Updated: August 5, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 29, 2016