AnaphylaxisANAPHYLASHOCKNCT04290507
Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit
An observational study of Anaphylaxis, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, accompanied with an increased number of hospitalizations. Although rare, this condition is often associated with a significant morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaphylaxis
- How many people
- 339 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to ICU following anaphylaxis
Who may be able to join
- Being > 18 years old
- suffered an anaphylactic reaction, regardless of the location or causative allergen
- transferred alive in an ICU
Who cannot join
- dead within less than one hour after admission
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital of Nancy
Nancy, 54511
University Hospital of Strasbourg
Strasbourg
About this study
Official title: Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit: a French Retrospective Multicenter Study
Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, accompanied with an increased number of hospitalizations. Although rare, this condition is often associated with a significant morbidity and mortality. The mortality rate has been recently estimated at 0.84 (95% CI, 0.79 to 0.88) per million per year in the French adult population. Age, chronic medication and cardiac or pulmonary comorbidities have been reported to increase the risk of a severe reaction. Obesity, age and cardiovascular comorbidities have been identified as risk factors for fatal anaphylaxis. However, the risk factors for death after ICU admission have not been elucidated yet.
- Conditions
- Anaphylaxis
- Keywords
- fluid management, mortality
- Medical subject headings
- Anaphylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
In-ICU mortality
The number of participants deceased within ICU hospitalisation
Measured: Day 30
Secondary outcomes (5)
Volume of fluid administered
The volume of fluid administered during priori to and during ICU stay, in millilitres will be noted
Measured: Day 30
Amount of epinephrine
Quantity of epinephrine administered during ICU stay
Measured: Day 30
Amount of norepinephrine
Quantity of norepinephrine administered during ICU stay
Measured: Day 30
Number and severity of organ failure
The severity of organ failure will be assessed with the SOFA score
Measured: Day 30
Extracorporeal life support requirement
The number of participants that required ECMO V/V or A/V
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Jan 2017
- Primary completion30 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290507
- Sponsor's protocol ID
- ANAPHYLASHOCK/Guerci
- Acronym
- ANAPHYLASHOCK
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guerci P, Tacquard C, Chenard L, Millard D, Soufir L, Malinovsky JM, Garot M, Lalot JM, Besch G, Louis G, Thion LA, Charpentier C, Kimmoun A, Danguy Des Deserts M, Carreira S, Plantefeve G, Novy E, Abraham P, Mertes PM; Societe Francaise d'Anesthesie et Reanimation (SFAR) Research Network. Epidemiology and outcome of patients admitted to intensive care after anaphylaxis in France: a retrospective multicentre study. Br J Anaesth. 2020 Dec;125(6):1025-1033. doi: 10.1016/j.bja.2020.08.024. Epub 2020 Sep 12.
PubMed 32928517
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit: a French Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04290507
- Acronym / sponsor ID
- ANAPHYLASHOCK / ANAPHYLASHOCK/Guerci
- Conditions
- Anaphylaxis
- Keywords
- fluid management, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, accompanied with an increased number of hospitalizations. Although rare, this condition is often associated with a significant morbidity and mortality. The mortality rate has been recently estimated at 0.84 (95% CI, 0.79 to 0.88) per million per year in the French adult population. Age, chronic medication and cardiac or pulmonary comorbidities have been reported to increase the risk of a severe reaction. Obesity, age and cardiovascular comorbidities have been identified as risk factors for fatal anaphylaxis. However, the risk factors for death after ICU admission have not been elucidated yet.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to ICU following anaphylaxis
Key inclusion criteria (3 listed)
- Being > 18 years old
- suffered an anaphylactic reaction, regardless of the location or causative allergen
- transferred alive in an ICU
Key exclusion criteria (1 listed)
- dead within less than one hour after admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-ICU mortality
Time frame: Day 30
The number of participants deceased within ICU hospitalisation
5 secondary outcomes
Volume of fluid administered
Time frame: Day 30
Amount of epinephrine
Time frame: Day 30
Amount of norepinephrine
Time frame: Day 30
Number and severity of organ failure
Time frame: Day 30
Extracorporeal life support requirement
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 32928517Guerci P, Tacquard C, Chenard L, Millard D, Soufir L, Malinovsky JM, Garot M, Lalot JM, Besch G, Louis G, Thion LA, Charpentier C, Kimmoun A, Danguy Des Deserts M, Carreira S, Plantefeve G, Novy E, Abraham P, Mertes PM; Societe Francaise d'Anesthesie et Reanimation (SFAR) Research Network. Epidemiology and outcome of patients admitted to intensive care after anaphylaxis in France: a retrospective multicentre study. Br J Anaesth. 2020 Dec;125(6):1025-1033. doi: 10.1016/j.bja.2020.08.024. Epub 2020 Sep 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anaphylaxis, run by Central Hospital, Nancy, France at 2 sites in France.
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 3 inclusion and 1 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 11 Mar 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-ICU mortality (time frame: Day 30). 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 NCT04290507, 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 11 Mar 2020.