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临床试验/NCT05422118
NCT05422118Unknown不适用

Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Saber Mohamed

resident doctor at clinical pathology department at faculty of medicine sohag university hospital

Sohag University

研究点 (1)

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