Hypersensitivity, ImmediateCADECAPNCT03918772
Clinical Determinants and Perioperative Allergic Reactions (CADECAP Study)
An observational study of Hypersensitivity, Immediate and Perioperative Period, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The clinical presentation of perioperative allergic and non-allergic clinical reactions is often considered undistinguishable while the accurate analysis of clinical cases shows striking clinical differences which might be predictive of the etiological diagnosis (allergic versus non-allergic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity, Immediate, Perioperative Period
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2018to 22 Mar 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: Patients having experienced a perioperative immediate hypersensitivity where the allergological assessment was performed by the collaborators of this study
Who may be able to join
- Patients having experienced a perioperative immediate hypersensitivity (including the obstetrical setting) according to one grade of the Ring and Messmer clinical scale, for whom:
- The clinical history is known and has been related to perioperative immediate hypersensitivity;
- The biological assessment including plasma histamine and/or tryptase (and serum IgE when available) was performed after the onset of immediate hypersensitivity according to current guidelines;
- The allergological assessment including skin tests performed by the collaborators of this study was carried out according to current guidelines in surviving patients
Who cannot join
- Patients who decline to be involved in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Determinants in Perioperative Allergic Immediate Hypersensitivity
The clinical presentation of perioperative allergic and non-allergic clinical reactions is often considered undistinguishable while the accurate analysis of clinical cases shows striking clinical differences which might be predictive of the etiological diagnosis (allergic versus non-allergic).
The four-step Ring and Messmer clinical scale helps to guide acute management of immediate hypersensitivity accordingly to the clinical presentation although this scale does not take into account the mechanism involved (i.e. allergic versus non-allergic). Non-allergic clinical reactions are usually non-life-threatening and may, sometimes, spontaneously resolve in contrast to allergic reactions which are mainly severe and life-threatening conditions, typically called anaphylaxis.
The cornerstones of anaphylaxis management are fluid therapy and epinephrine. However, poor outcome has been reported as a result of delayed treatment and/or inappropriate management of perioperative anaphylaxis.
Read the detailed description
The main objectives of this study are to: i) characterize the clinical and paraclinical determinants of IgE-mediated allergy that could be correlated to the ultimate diagnosis; and ii) elaborate a decision-making algorithm for clinical patterns identification of perioperative allergic reactions to guide acute management, thus potentially decreasing the related morbidity and mortality.
The secondary objectives are to: i) suggest a modification of the Ring and Messmer scale according to the phenotypes involved; ii) identify the clinical characteristics of isolated non-allergic bronchospasm; iii) compare the most frequent agents involved in perioperative IgE-mediated allergy to those reported in the international studies; iv) identify the negative predictive values of skin tests in allergic and non-allergic patients; v) compare the therapeutic modalities used to those recommended in the literature; vi) describe the cases of morbidity and mortality and identify the potential risk factors.
The Ring and Messmer scale is used to quote the clinical features occurring in drug- or latex-induced immediate hypersensitivity and has been adapted to the perioperative setting as follows:
Grade I: Muco-cutaneous signs only (generalized erythema and/or extensive urticaria and/or angioedema) Grade II: Mucocutaneous signs, hypotension, tachycardia and/or moderate bronchospasm Grade III: Mucocutaneous signs, cardiovascular collapse, tachycardia or bradycardia, bronchospasm, digestive signs Grade IV: Cardiac arrest Grade V: Death
Perioperative immediate hypersensitivity reaction requires further allergologic assessment.
The allergologic assessment is performed a few weeks after the reaction to confirm or disprove an allergic mechanism behind the reaction (i.e. allergy versus non-allergy), and to identify culprit agent(s) and safe drugs, including suitable alternatives. It is based on the review of the details of the reaction along with histamine and/or tryptase levels and specific Immunoglobulin E levels (when available) and skin tests results.
Plasma histamine and/or tryptase levels and Immunoglobulin E levels are measured at the time of the reaction. Acute tryptase levels are compared to baseline tryptase measured at least 24 hours after the reaction or when the patient is referred for allergological investigation. Skin tests, including prick-tests and intradermal tests, are performed during the allergological assessment.
- Conditions
- Hypersensitivity, Immediate, Perioperative Period
- Keywords
- Anaphylaxis, Epinephrine, Hypersensitivity, Immediate, Morbidity, Mortality, Perioperative Period, Skin Tests, Tryptases
- Medical subject headings
- Hypersensitivity, Immediate, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative immediate hypersensitivity | Patients having experienced perioperative immediate hypersensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the predictive muco-cutaneous signs of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
muco-cutaneous signs (generalized erythema and/or extensive urticaria and/or angioedema)
Measured: From date of the perioperative clinical reaction up to 6 hours
Identification of the predictive heart rate of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
heart rate (beat/min.)
Measured: From date of the perioperative clinical reaction up to 6 hours
Identification of the predictive arterial pressure of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
arterial pressure (mmHg)
Measured: From date of the perioperative clinical reaction up to 6 hours
Identification of the predictive upper gastrointestinal symptoms of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
digestive signs (vomiting)
Measured: From date of the perioperative clinical reaction up to 6 hours
Identification of the predictive lower gastrointestinal symptoms of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
digestive signs (diarrhea)
Measured: From date of the perioperative clinical reaction up to 6 hours
Identification of recurrence of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
recurrence of symptoms following a symptom-free response
Measured: From date of the perioperative clinical reaction up to 6 hours
Secondary outcomes (8)
Drugs involved in adverse reactions as assessed by the Ring and Messmer clinical scale
To identify the drugs involved in the onset of perioperative allergic clinical reactions and compare our results to those provided in the different international epidemiologic studies regarding perioperative immediate hypersensitivity.
Measured: From date of the perioperative clinical reaction and up to 100 months
Negative predictive values of skin tests in allergic and non-allergic patients
Negative skin-tested agents administered according to the results of allergological follow-up during subsequent anesthetics in allergic and non-allergic patients
Measured: Up to 5 years after the allergologic follow-up
Participants with treatment-related adverse events as assessed by by CTCAE v4.0 and fluid therapy
To identify the number of patients who received fluid therapy (volume, type) in allergic hypersensitivity
Measured: Through study completion, an average of 2 years
participants with treatment-related adverse events as assessed by CTCAE v4.0 and vasoconstrictive agents
To identify the number of patients who received vasoconstrictive agents (ephedrine, neosynephrine, epinephrine, norepinephrine) and corresponding cumulative doses
Measured: Through study completion, an average of 2 years
participants with treatment-related adverse events as assessed by CTCAE v4.0 and salbutamol and/or steroids
To identify the number of patients who received salbutamol, steroids and corresponding doses
Measured: Through study completion, an average of 2 years
Participants with treatment-related adverse events as assessed by CTCAE v4.0 and intensive care unit admission
To identify the number of patients who were admitted in intensive care unit
Measured: Through study completion, an average of 2 years
Participants with treatment-related adverse events as assessed by CTCAE v4.0 and morbidity
To report the morbidity cases including cardiac and/or renal and/or hepatic and/or neurologic failure(s) after perioperative allergic immediate hypersensitivity
Measured: Through study completion, an average of 2 years
Participants with treatment-related adverse events as assessed by CTCAE v4.0 and mortality
To report the mortality cases after perioperative allergic immediate hypersensitivity
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start5 Nov 2018
- Primary completion5 Nov 2018
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity, ImmediateStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale Dewachter, M.D., Ph.D., Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918772
- Sponsor's protocol ID
- 2018-043
- Acronym
- CADECAP
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Determinants in Perioperative Allergic Immediate Hypersensitivity
- ClinicalTrials.gov ID
- NCT03918772
- Acronym / sponsor ID
- CADECAP / 2018-043
- Conditions
- Hypersensitivity, Immediate, Perioperative Period
- Keywords
- Anaphylaxis, Epinephrine, Hypersensitivity, Immediate, Morbidity, Mortality, Perioperative Period, Skin Tests, Tryptases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 18 Apr 2019 (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.
The clinical presentation of perioperative allergic and non-allergic clinical reactions is often considered undistinguishable while the accurate analysis of clinical cases shows striking clinical differences which might be predictive of the etiological diagnosis (allergic versus non-allergic).
The four-step Ring and Messmer clinical scale helps to guide acute management of immediate hypersensitivity accordingly to the clinical presentation although this scale does not take into account the mechanism involved (i.e. allergic versus non-allergic). Non-allergic clinical reactions are usually non-life-threatening and may, sometimes, spontaneously resolve in contrast to allergic reactions which are mainly severe and life-threatening conditions, typically called anaphylaxis.
The cornerstones of anaphylaxis management are fluid therapy and epinephrine. However, poor outcome has been reported as a result of delayed treatment and/or inappropriate management of perioperative anaphylaxis.
Detailed description
The main objectives of this study are to: i) characterize the clinical and paraclinical determinants of IgE-mediated allergy that could be correlated to the ultimate diagnosis; and ii) elaborate a decision-making algorithm for clinical patterns identification of perioperative allergic reactions to guide acute management, thus potentially decreasing the related morbidity and mortality.
The secondary objectives are to: i) suggest a modification of the Ring and Messmer scale according to the phenotypes involved; ii) identify the clinical characteristics of isolated non-allergic bronchospasm; iii) compare the most frequent agents involved in perioperative IgE-mediated allergy to those reported in the international studies; iv) identify the negative predictive values of skin tests in allergic and non-allergic patients; v) compare the therapeutic modalities used to those recommended in the literature; vi) describe the cases of morbidity and mortality and identify the potential risk factors.
The Ring and Messmer scale is used to quote the clinical features occurring in drug- or latex-induced immediate hypersensitivity and has been adapted to the perioperative setting as follows:
Grade I: Muco-cutaneous signs only (generalized erythema and/or extensive urticaria and/or angioedema) Grade II: Mucocutaneous signs, hypotension, tachycardia and/or moderate bronchospasm Grade III: Mucocutaneous signs, cardiovascular collapse, tachycardia or bradycardia, bronchospasm, digestive signs Grade IV: Cardiac arrest Grade V: Death
Perioperative immediate hypersensitivity reaction requires further allergologic assessment.
The allergologic assessment is performed a few weeks after the reaction to confirm or disprove an allergic mechanism behind the reaction (i.e. allergy versus non-allergy), and to identify culprit agent(s) and safe drugs, including suitable alternatives. It is based on the review of the details of the reaction along with histamine and/or tryptase levels and specific Immunoglobulin E levels (when available) and skin tests results.
Plasma histamine and/or tryptase levels and Immunoglobulin E levels are measured at the time of the reaction. Acute tryptase levels are compared to baseline tryptase measured at least 24 hours after the reaction or when the patient is referred for allergological investigation. Skin tests, including prick-tests and intradermal tests, are performed during the allergological assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perioperative immediate hypersensitivity | – | –Patients having experienced perioperative immediate hypersensitivity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having experienced a perioperative immediate hypersensitivity where the allergological assessment was performed by the collaborators of this study
Key inclusion criteria (4 listed)
- Patients having experienced a perioperative immediate hypersensitivity (including the obstetrical setting) according to one grade of the Ring and Messmer clinical scale, for whom:
- The clinical history is known and has been related to perioperative immediate hypersensitivity;
- The biological assessment including plasma histamine and/or tryptase (and serum IgE when available) was performed after the onset of immediate hypersensitivity according to current guidelines;
- The allergological assessment including skin tests performed by the collaborators of this study was carried out according to current guidelines in surviving patients
Key exclusion criteria (1 listed)
- Patients who decline to be involved in the study
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
Identification of the predictive muco-cutaneous signs of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
Time frame: From date of the perioperative clinical reaction up to 6 hours
muco-cutaneous signs (generalized erythema and/or extensive urticaria and/or angioedema)
Identification of the predictive heart rate of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
Time frame: From date of the perioperative clinical reaction up to 6 hours
heart rate (beat/min.)
Identification of the predictive arterial pressure of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
Time frame: From date of the perioperative clinical reaction up to 6 hours
arterial pressure (mmHg)
Identification of the predictive upper gastrointestinal symptoms of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
Time frame: From date of the perioperative clinical reaction up to 6 hours
digestive signs (vomiting)
Identification of the predictive lower gastrointestinal symptoms of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
Time frame: From date of the perioperative clinical reaction up to 6 hours
digestive signs (diarrhea)
Identification of recurrence of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
Time frame: From date of the perioperative clinical reaction up to 6 hours
recurrence of symptoms following a symptom-free response
8 secondary outcomes
Drugs involved in adverse reactions as assessed by the Ring and Messmer clinical scale
Time frame: From date of the perioperative clinical reaction and up to 100 months
Negative predictive values of skin tests in allergic and non-allergic patients
Time frame: Up to 5 years after the allergologic follow-up
Participants with treatment-related adverse events as assessed by by CTCAE v4.0 and fluid therapy
Time frame: Through study completion, an average of 2 years
participants with treatment-related adverse events as assessed by CTCAE v4.0 and vasoconstrictive agents
Time frame: Through study completion, an average of 2 years
participants with treatment-related adverse events as assessed by CTCAE v4.0 and salbutamol and/or steroids
Time frame: Through study completion, an average of 2 years
Participants with treatment-related adverse events as assessed by CTCAE v4.0 and intensive care unit admission
Time frame: Through study completion, an average of 2 years
Participants with treatment-related adverse events as assessed by CTCAE v4.0 and morbidity
Time frame: Through study completion, an average of 2 years
Participants with treatment-related adverse events as assessed by CTCAE v4.0 and mortality
Time frame: Through study completion, an average of 2 years
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 6 Apr 2026.
- 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.
Pascale Dewachter, M.D., Ph.D. study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity, Immediate and Perioperative Period, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Identification of the predictive muco-cutaneous signs of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale (time frame: From date of the perioperative clinical reaction up to 6 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.