Smoke Inhalation PatientsRISKNCT01386788
European Survey: Risk of Cyanide Poisoning in Smoke Inhalation
An observational study of Smoke Inhalation Patients, run by Dr. Ernst MW Koch at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoke Inhalation Patients
- Type of treatment
- Injection or infusion
- How many people
- 102 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2009to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with smoke inhalation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Prof. Dr. Götz Geldner
Ludwigsburg, 71640
Prof. Th. Zilker
München, 81675
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Smoke Inhalation Patients
- Being tested
- There is no intervention planned (observational)
- Keywords
- Smoke, cyanide, closed space fires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention planned (observational)Other
No intervention foreseen
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: There is no intervention planned (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival After 24 Hours
Number of participants who survived at 24 hours after smoke inhalation were reported.
Measured: 24 hours
Serum Cyanide Levels
Measured: blood sampling within 2 hours after smoke inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoke Inhalation PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ernst MW Koch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Ernst MW Koch, Dr. Ernst MW Koch
- Investigators
- Thomas Zilker, Prof., Study chair, TU MünchenCarlo A Locatelli, Prof, Study chair, IRCCS Fondazione MaugeriFrédéric Baud, Prof, Study chair, Hopital LariboisièreGuillermo Burillo-Putze, Prof, Study chair, Universidad de TeneriffeJean-Philippe Fauville, Dr, Study chair, To be addedFrancois Levy, Dr, Study chair, To be added
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386788
- Sponsor's protocol ID
- EML015722-600
- Other IDs
- 2009-010202-11, 2009
- Acronym
- RISK
- Status last verified
- Aug 2016
- First submitted
- 27 Jun 2011
- Last updated
- 28 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Geldner G, Koch EM, Gottwald-Hostalek U, Baud F, Burillo G, Fauville JP, Levi F, Locatelli C, Zilker T. Report on a study of fires with smoke gas development : determination of blood cyanide levels, clinical signs and laboratory values in victims. Anaesthesist. 2013 Aug;62(8):609-16. doi: 10.1007/s00101-013-2209-3. Epub 2013 Aug 7.
PubMed 23917894
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Survey: Risk of Cyanide Poisoning in Smoke Inhalation, Symptoms, Key Treatment and Outcome (RISK)
- ClinicalTrials.gov ID
- NCT01386788
- Acronym / sponsor ID
- RISK / EML015722-600
- Conditions
- Smoke Inhalation Patients
- Keywords
- Smoke, cyanide, closed space fires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Dr. Ernst MW KochUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Posted 28 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoke Inhalation patients | – | Other: There is no intervention planned (observational)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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with smoke inhalation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention planned (observational)No intervention foreseen | Other | Smoke Inhalation patients |
Primary outcome
Overall Survival After 24 Hours
Time frame: 24 hours
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23917894Geldner G, Koch EM, Gottwald-Hostalek U, Baud F, Burillo G, Fauville JP, Levi F, Locatelli C, Zilker T. Report on a study of fires with smoke gas development : determination of blood cyanide levels, clinical signs and laboratory values in victims. Anaesthesist. 2013 Aug;62(8):609-16. doi: 10.1007/s00101-013-2209-3. Epub 2013 Aug 7.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Zilker, Prof. study chair
TU München
Carlo A Locatelli, Prof study chair
IRCCS Fondazione Maugeri
Frédéric Baud, Prof study chair
Hopital Lariboisière
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoke Inhalation Patients, run by Dr. Ernst MW Koch at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival After 24 Hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01386788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.