Escalade or Deseacalade Antibiotic Use in Severe Acute Pancreatitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pancreatic or peripancreatic infection
研究概览
简要总结
Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better.
详细描述
SAP is a serious and life-threatening disease and requires intensive and aggressive management of multiple organ failure and severe infectious complications that can develop in these patients. The most common cause of death in patients suffering from severe acute pancreatitis (SAP) is the infection of pancreatic necrosis by enteric bacteria with mortality rates of 30% (range 14- 62%),spurring the discussion of whether or not prophylactic antibiotic administration could be a beneficial approach. Pancreatic infections are more often monomicrobial, especially E. coli in the two first weeks (100% and 62.5%) of onset, with a shift from gram-negative to gram-positive as the pancreatitis progressed.
In order to evaluate the benefit of prophylactic antibiotic application, a number of randomized controlled clinical trials have been published over the past 15 years. Since the results were conflicting and most studies were of low methodological quality and/or statistically underpowered, meta-analyses have been performed to assess this important issue. However, their results ranged from absolutely no effect of antibiotic prophylaxis to positive effects regarding mortality, the incidence of infected pancreatic necrosis and the incidence of extra pancreatic infections.
In order to provide reliable evidence of the effect of antibiotherapy strategy in SAP, we performed a prospective randomized multicenter clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe Acute Pancreatitis according to Atlanta criteria revisited in 2012
排除标准
- •concurrent sepsis or (peri)pancreatic infection caused by a second disease
- •patients with chronic organ failure (chronic renal failure needs kidney replacement, chronic heart failure, decompensate hepatic cirrhosis, chronic obstructive pulmonary disease)
- •recurrent or endoscopic retrograde cholangiopancreatography (ERCP), or traumatic or operative pancreatitis
- •pregnancy, malignancy or immunodeficiency
- •a history of allergy to meropenem, cefoperazone and metronidazole
- •a history of antibiotic administration within 48 h prior to enrollment
- •possible death within 48 h after enrollment
研究组 & 干预措施
cefoperazone + metronidazole
cefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition
干预措施: oral care by chlorhexidine gluconate (Procedure)
cefoperazone + metronidazole
cefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition
干预措施: enteral nutrition (Procedure)
cefoperazone + metronidazole
cefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition
干预措施: Somatostatin (Drug)
cefoperazone + metronidazole
cefoperaozone 2g q8h + MDZ 0.5g q8h Oral care Somatostatin 3-6mg per 24h enteral nutrition
干预措施: Meropenem (Drug)
meropenem
Meropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition
干预措施: cefoperazone + metronidazole (Drug)
meropenem
Meropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition
干预措施: oral care by chlorhexidine gluconate (Procedure)
meropenem
Meropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition
干预措施: enteral nutrition (Procedure)
meropenem
Meropenem 0.5g q6h or adapted with renal function. Oral care Somatostatin 3-6mg per 24h enteral nutrition
干预措施: Somatostatin (Drug)
结局指标
主要结局
pancreatic or peripancreatic infection
时间窗: 28-day
次要结局
- cost of management of SAP(90-day)
- Microbiology resistance(90-day)
研究者
Erzhen Chen
Professer
Ruijin Hospital
