Clinical Determinants and Perioperative Allergic Reactions (CADECAP Study)

NCT03918772 | Completed

• 1 other identifier: 2018-043
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hypersensitivity, Immediate; Perioperative Period

Keywords

Anaphylaxis; Epinephrine; Hypersensitivity, Immediate; Morbidity; Mortality; Perioperative Period; Skin Tests; Tryptases

Outcome Measures

Primary Outcomes (6)

• 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)

  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.)

  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)

  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)

  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)

  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

  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

  From date of the perioperative clinical reaction and up to 100 months

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

  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

  Through study completion, an average of 2 years

• participants with treatment-related adverse events as assessed by CTCAE v4.0 and vasoconstrictive agents

  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

  Through study completion, an average of 2 years

Study Arms (1)

Perioperative immediate hypersensitivity

Patients having experienced perioperative immediate hypersensitivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having experienced a perioperative immediate hypersensitivity where the allergological assessment was performed by the collaborators of this study

You may qualify if:

• 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

You may not qualify if:

• Patients who decline to be involved in the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique-Hôpitaux de Paris

Paris, 75004, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Hypersensitivity, Immediate; Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity; Immune System Diseases

Study Officials

• Pascale Dewachter, M.D., Ph.D.

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: April 18, 2019
• Study Start: November 5, 2018
• Primary Completion: November 5, 2018
• Study Completion: March 22, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)