The Role of Prophylactic Antibiotics in Prevention of Spontaneous Bacterial Peritonitis in Compensated Liver Cirrhosis With Upper Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Prophylactic antibiotics in cirrhotic patients.
研究概览
简要总结
timely short-term antibiotic prophylaxis is an essential step in the management of these patients . Prophylaxis must be instituted as early as variceal hemorrhage is suspected, and timely administration has been associated with a reduced re-bleeding rate and lower mortality .
More recently, the American Association for the Study of Liver Diseases (AASLD), the Department of Veterans Affairs (VA), and the American Society for Gastrointestinal Endoscopy (ASGE) recommended antibiotic prophylaxis in all cirrhotic patients with UGIB, regardless of its source (i.e. variceal or non-variceal) or the presence of ascites.
详细描述
cute variceal bleeding is one of the major causes of death in cirrhotic patients . It is also the major cause of upper gastrointestinal (GI) bleeding in cirrhotic patients, accounting for 70% of cases . Mortality during the first episode is estimated to 15-20% but is higher in severe patients (Child Pugh C), at around 30%, whereas it is very low in patients with compensated cirrhosis (Child Pugh A).
Hemorrhage from gastro-esophageal varices is a devastating complication of portal hypertension. Although the in-hospital mortality of acute variceal bleeding was up to 40% about 20 years ago, it was decreased to about 15-20% in recent years.20 One of the main reasons in the decrease of mortality has been ascribed to the alertness of clinicians in the treatment and prophylaxis of associated bacterial infections. The prevalence of bacterial infections in cirrhotic patients with gastrointestinal hemorrhage has been up to 52%-66%.
Therefore, timely short-term antibiotic prophylaxis is an essential step in the management of these patients. Prophylaxis must be instituted as early as variceal hemorrhage is suspected, and timely administration has been associated with a reduced re-bleeding rate and lower mortality .
More recently, the American Association for the Study of Liver Diseases (AASLD), the Department of Veterans Affairs (VA), and the American Society for Gastrointestinal Endoscopy (ASGE) recommended antibiotic prophylaxis in all cirrhotic patients with UGIB, regardless of its source (i.e. variceal or non-variceal) or the presence of ascites.
The importance of prophylaxis is incontrovertible in patients with advanced cirrhosis, whereas in patients with less severe disease, conflicting data have been published. In a retrospective study, Child A patients had a low rate of bacterial infection (2%) in the absence of antibiotic prophylaxis, and there was no difference in mortality between patients on and off antibiotics .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child score "A" Cirrhotic patients
- •Hematemesis and / or melena.
排除标准
- •Patient with unsuccessful endoscopic hemostasis
- •Patients who already have signs of infections (elevation in the body temperature, elevation in white blood cells above 10,000 cell/mmᵌ);
- •Patients with occult infection (defined as positive blood cultures obtained before antibiotic prophylaxis)
- •Patients using antibiotics before endoscopy.
- •Patients refuse to participate in the study.
研究组 & 干预措施
Role of prophylactic antibiotics in childscore A
Role of prophylaxis against infections in progression of cirrhotic patients with childscore A
干预措施: Third generation cephalosporin antibiotics (Drug)
结局指标
主要结局
Prophylactic antibiotics in cirrhotic patients.
时间窗: 1 year
Rate of infection in patients using prophylactic antibiotics in Child A cirrhotic patients presented with upper gastrointestinal bleeding according to blood culture and chest x ray.
次要结局
未报告次要终点
研究者
Nariman Gamal Abd Elhakeem
Principal investigator
Assiut University