Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ascitic Fluid calprotectin
研究概览
简要总结
Spontaneous bacterial peritonitis (SBP) is an infection of the ascitic fluid in patients with liver cirrhosis and portal hypertension. There is no obvious surgical cause as perforation or intraabdominal inflammatory focus as abscess. Up to 30% of the ascitic patients will develop SBP.
SBP is attributed to immune dysfunction, bacterial translocation, circulatory dysfunction and inflammatory status. SBP is diagnosed by ascitic fluid analysis . SBP was defined as polymorphonuclear leucocyte count (PMN) >250/mm3 in ascitic fluid, . Not all cases are associated with positive ascitic fluid cultures.
There are variants of ascitic fluid infections as culture-negative neutrocytic ascites, monomicrobial non-neutrocytic bacterascites, polymicrobial bacterascites and secondary bacterial peritonitis.
The advent of the SBP carries a poor prognosis where the hospital mortality ranged from 10 to 50%. As a consequence, any patient with SBP should be assessed for liver transplantation. Immediate treatment with antibiotics and IV albumin should be initiated.
Studies were conducted on alternatives of the ascitic PMN count as high sensitivity C-reactive protein (hsCRP), serum procalcitonin, urinary lipocalin, ascitic lactoferrin, homocysteine and fecal or ascitic calprotectin.
The gold standard test for SBP is ascitic fluid analysis with measurement of the PMN. It is useful for the diagnosis and monitoring of treatment. The culture of the ascitic fluid may be positive if was done correctly .
There is a variant of SBP that is called culture-negative neutrocytic ascites. It is characterized by elevated ascitic fluid PMN but the culture is negative. It is managed exactly as classic SBP. Such cases would be missed if cultures were not done The manual PMN counting is time consuming, laborious and required some experience to avoid intra- and inter-observer variability. So, a simple rapid bedside test would be useful clinically.
Calprotectin is acute-phase inflammatory protein that is released from the PMN. Calprotectin has anti-proliferative and antimicrobial properties. Calprotectin is used clinically widespread in the diagnosis and monitoring treatment of inflammatory bowel disease .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients were divided into two groups:
- •Non-SBP group: it included 25 patients with cirrhotic ascites without clinical or laboratory evidence of SBP.
- •SBP group: it included 25 patients with cirrhotic ascites with SBP. They were diagnosed by positive ascitic fluid bacterial culture, an increase in PMNLs count in ascites (>250 cells/mm3) and without any intra-abdominal source of infection.
排除标准
- •(1) Cirrhotic patients with and without SBP receiving antibiotics in last 1 week.
- •(2) Recent abdominal surgery (<3 months). (3) abdominal malignancy [hepatocellular carcinoma (HCC), colorectal carcinoma, gastric carcinoma, pancreatic carcinoma, cholangiocarcinoma].
- •(4) Intra-abdominal infected lesions, such as abscess, appendicitis, cholecystitis, and pancreatitis.
- •(5) History of inflammatory bowel disease (Crohn's disease, ulcerative colitis).
- •(6) patients with heart failure (HF), hematological, and autoimmune disorders were excluded.
结局指标
主要结局
Ascitic Fluid calprotectin
时间窗: 6 months
ascitic fluid calprotectin by ELISA
INR
时间窗: 6 months
international normalization time
2-liver function test
时间窗: 6 months
AlT,ASt,Albumin,total protein,bilirubin
4-Ascitic fluid analysis(physical,chemical,microscopic)
时间窗: 6 months
physical(colour,aspect) chemical(protien,glucose) microscopical(wbcs total and differential,Rbcs),bacterial culture
1-CBC
时间窗: 6 months
WBCs count and differential,RBCs count,HB,mcv,Mch,Mchc,platelete count
3-Renal function test
时间窗: 6 months
serum create and urea
次要结局
未报告次要终点
研究者
Alaa Saber Mohamed
resident doctor at clinical pathology department at faculty of medicine sohag university hospital
Sohag University
