Clinical Determinants in Perioperative Allergic Immediate Hypersensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Identification of the predictive muco-cutaneous signs of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who decline to be involved in the study
研究组 & 干预措施
Perioperative immediate hypersensitivity
Patients having experienced perioperative immediate hypersensitivity
结局指标
主要结局
Identification of the predictive muco-cutaneous signs of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
时间窗: 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 recurrence of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
时间窗: From date of the perioperative clinical reaction up to 6 hours
recurrence of symptoms following a symptom-free response
Identification of the predictive upper gastrointestinal symptoms of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
时间窗: From date of the perioperative clinical reaction up to 6 hours
digestive signs (vomiting)
Identification of the predictive heart rate of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
时间窗: 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
时间窗: From date of the perioperative clinical reaction up to 6 hours
arterial pressure (mmHg)
Identification of the predictive lower gastrointestinal symptoms of perioperative allergic immediate hypersensitivity as assessed by the Ring and Messmer clinical scale
时间窗: From date of the perioperative clinical reaction up to 6 hours
digestive signs (diarrhea)
次要结局
- Participants with treatment-related adverse events as assessed by CTCAE v4.0 and mortality(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 intensive care unit admission(Through study completion, an average of 2 years)
- Participants with treatment-related adverse events as assessed by CTCAE v4.0 and morbidity(Through study completion, an average of 2 years)
- Negative predictive values of skin tests in allergic and non-allergic patients(Up to 5 years after the allergologic follow-up)
- 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)
- 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 salbutamol and/or steroids(Through study completion, an average of 2 years)