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Completed

NCT Number: NCT03918772

Clinical Determinants and Perioperative Allergic Reactions (CADECAP Study)

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.

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Key information

Conditions

Hypersensitivity, Immediate Anaphylaxis Hypersensitivity Immune System Diseases Perioperative Period

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique-Hôpitaux de Paris

Paris, 75004, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients who decline to be involved in the study

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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.)

  3. 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)

  4. 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)

  5. 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)

  6. 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

Secondary outcomes

  1. 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

    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.

  2. Negative predictive values of skin tests in allergic and non-allergic patients

    Time frame: Up to 5 years after the allergologic follow-up

    Negative skin-tested agents administered according to the results of allergological follow-up during subsequent anesthetics in allergic and non-allergic patients

  3. 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

    To identify the number of patients who received fluid therapy (volume, type) in allergic hypersensitivity

  4. 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

    To identify the number of patients who received vasoconstrictive agents (ephedrine, neosynephrine, epinephrine, norepinephrine) and corresponding cumulative doses

  5. 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

    To identify the number of patients who received salbutamol, steroids and corresponding doses

  6. 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

    To identify the number of patients who were admitted in intensive care unit

  7. Participants with treatment-related adverse events as assessed by CTCAE v4.0 and morbidity

    Time frame: Through study completion, an average of 2 years

    To report the morbidity cases including cardiac and/or renal and/or hepatic and/or neurologic failure(s) after perioperative allergic immediate hypersensitivity

  8. Participants with treatment-related adverse events as assessed by CTCAE v4.0 and mortality

    Time frame: Through study completion, an average of 2 years

    To report the mortality cases after perioperative allergic immediate hypersensitivity

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Clinical Determinants in Perioperative Allergic Immediate Hypersensitivity

Acronym: CADECAP

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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