Complicated Intra-abdominal Infections - the Greek Reality: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Morbidity
研究概览
简要总结
Complicated Intra-Abdominal Infections (cIAIs) represent an emergent surgical situation which lead to important non trauma-related mortality in several Emergency Surgical Centers worldwide. Their prevalence seemed to be unrelated to age, gender, health status and socioeconomic condition. Early diagnosis, timely septic source control, wide-spectrum antibiotic delivery and resuscitation with fluids and vasoactive agents in critically ill patients are fundamentals for successful cIAIs management. Moreover, septic shock, antibiotic resistant multi-pathogens and comorbidities have been associated with increased morbidity and mortality of cIAIs.
Several international health associations announce updated guidelines for cIAIs management. Nevertheless, such guidelines could not be widely implemented, because of specific features of several healthcare systems worldwide. The aim of the present study is to investigate the prevalence of cIAIs among the Greek health system and the potential association of time interval of septic source control, preoperative resuscitation and multidrug resistant pathogens with morbidity, mortality, ICU stay and length of stay in patients with cIAIs.
详细描述
Registry of patients with complicated intra-abdominal infections including:
- Patient demographics (gender, age, Carlson Comorbidity Index, cancer history/chemotherapy during the last 6 months, health unit stay during the last 6 months)
- Management (conservative, minimally invasive, surgical)
- Minimally invasive procedure - type (CT-guided drainage, endoscopic)
- Surgical procedure - type (open or laparoscopic, day or night, procedure description)
- Cultures (blood, peritoneal fluid, tissue)
- Time of diagnosis (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, white cell count, CRP)
- Just before procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, vasoactive agent delivery, intubation)
- Intraoperative parameters (time interval between diagnosis and intervention, WSES score, operative time, open abdomen, VAC)
- After procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, vasoactive agent delivery, intubation)
- Empirical wide-spectrum antibiotics (type and time interval from diagnosis)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Signed consent from patient or authorized representative
- •Complicated Intra-Abdominal Infection
- •Acute appendicitis with localized or diffuse peritonitis
- •Grade II or Grade III acute cholecystitis (Tokyo guidelines)
- •Visceral organ perforation with peritonitis
- •Bowel perforation after colonoscopy
- •Complicated diverticulitis (WSES classification)
- •Anastomotic leaks with abscess, localized or diffuse peritonitis
排除标准
- •Age < 18 years old
- •No signed consent from patient or authorized representative
结局指标
主要结局
Morbidity
时间窗: 30 days
Overall complications due to complicated intra-abdominal infections
次要结局
- Multidrug resistant pathogen cultures(30 days)
- Length of stay(30 days)
- Length of ICU stay(30 days)
- Organ failure(30 days)
- Re-operation rate(30 days)
- Mortality(30 days)
研究者
Maximos Frountzas
Dr Maximos Frountzas MD MPA PhD
National and Kapodistrian University of Athens