Complement Diagnosis of Acute Appendicitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Complement Activation differential diagnosis of Acute Appendicitis in a patient cohort presenting with Right Iliac Fosse Pain
研究概览
简要总结
Acute appendicitis is a common condition requiring urgent surgery but is often difficult to distinguish from other non-surgical conditions such as urinary infections, pelvic inflammatory disease and non-specific abdominal pain. Delay in diagnosis can result in significant morbidity and potential mortality. Currently, there is no one diagnostic test available and raised inflammatory markers such as C-reactive protein (CRP) and White Blood Count (WBC) along with an evolving clinical picture, help guide management. However, these markers are slow to respond to inflammation and are non-specific for appendicitis. The Complement cascade is an immune response to inflammation and infection involving three pathways which activate a number of proteins in the blood. Monitoring the absolute levels of these proteins should provide a faster and differential diagnostic test. The investigators propose a pilot trial to measure concentrations of Complement cascade activation biomarkers in the blood during hospital admissions for acute right lower abdominal pain, a symptom of appendicitis. Further, analysis of the differential Complement cascade pathway activation could potentially identify underlying pathology allowing the clinicians to target therapies.
详细描述
The proposed study is a pilot study on a cohort of participants recruited at emergency admission with acute right iliac fossa pain (right lower abdominal pain) to the Royal Devon & Exeter Hospital Accident & Emergency department. The pilot trial will collect one urine sample on admission and blood over a time course for each patient to record blood plasma levels of Complement proteins during hospital admissions with suspected appendicitis. The assay schedule is detailed in Table 1 below. The trial will perform additional Complement cascade activation tests on routine blood samples taken during the patient's stay in hospital. In addition 3 trial samples will be taken at time intervals that will capture the early Complement cascade response. Those patients going onto surgery will have a total of 5 additional trial samples taken, with 2 samples taken intra-operatively whilst under anaesthesia. From our previous experience in a similar pilot study CPOP (Complement cascade Predictors of Procedural Outcome), the investigators have introduced a blood taking 'curfew window' in which trial sample No. 2 & 3 must not take place between the hours of midnight and 0600 hrs. This is to incorporate the wishes of patients and improve compliance with the study. Sample analysis will be performed in parallel in the clinical chemistry laboratory for assays of CRP and the complement proteins C3 and C4. The additional trial assays will be performed by Prof Shaw's research post doctoral assistant in the clinical chemistry laboratory and in the Medical School. A fresh frozen urine sample will be acquired from the routine urine sample given on all admissions for RIF pain. This urine sample will be analysed for Complement activation products such as C3a and C5a. Diagnostic end points will be acquired through the routine management of these patients and accessed via the hospital imaging (PACS) and pathology (IHCS) reporting system. These will include appendix histology and microbiology, urinalysis, blood cultures, imaging and cervical swabs.
Table 1Blood Sample Assay Schedule Time Point Time of Test Routine Test Additional Trial Test Trial Assays Day Timings (example) PM Timings (example)
- t = 0 Admission to A&E
CONSENT ROUTINE:
WCC, CRP, LFTs, Amylase, Clotting. Urinalysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Admission for right iliac fossa pain
排除标准
- •Under 18 years unwilling to provide informed consent pregnant women diabetic immunosuppressed immunosuppression or steroid treatment within last 12 months learning disability Non-english speakers
结局指标
主要结局
Complement Activation differential diagnosis of Acute Appendicitis in a patient cohort presenting with Right Iliac Fosse Pain
时间窗: up to 5 days
C3 and C4 plasma concentration were measured in units of g/L over the time course t= admission, 4,8,12,23,47,71 hours or until discharge. Activation measures were derived as C3 and C4 differences at time each time point compared with admission values to derive changes in concentration which were compared in patients with a positive pathology diagnosis of the excised appendix (AA Group) and patients with a negative pathology diagnosis of the excised appendix or those patients discharged without appendectomy (non-AA Group).
次要结局
- clinical Alvarado Score(up to 5 days)
- The clinical Alvarado Score modified to include CRP > 5 mg/L - score 1(up to 5 days)
- Complement Activation C3a in Urine(up to 5 days)
- Complement Activation Terminal Cascade Complex(up to 5 days)
- Complement Activation Derived from C3dg(up to 5 days)
- C Reactive Protein Acute Phase Marker(up to 5 days)