Cirrhotic ascites
Conditions
Interventions
3. Adjudication independently by an infectious disease specialist and two liver disease experts.
Gold Standard:Clinical composite diagnosis (2017 Chinese guidelines) that incorporated:
1. Clinical signs or symptoms
2. Laboratory test abnormalities
Index test:total bacterial DNA quantification, Gram-positive bacterial DNA quantification, Gram-negative bacterial DNA quantification
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age from 18 to 75 years old, male or female; 2. The diagnostic criteria for cirrhosis are the evidence of hepatocyte synthesis dysfunction or portal hypertension by imaging biochemistry or hematology examination, or the histology conforms to the diagnosis of cirrhosis, and the etiology is not limited; 3. Patients with spontaneous bacterial peritonitis, referencing to China's 2017 "guidelines on the management of ascites and its related complications in cirrhosis". One or more of the following signs or symptoms are present: (1) Acute peritonitis: abdominal pain, abdominal tenderness or rebound tenderness, an increase in abdominal muscular tension, vomiting, and diarrhea or intestinal obstruction; (2) Systemic inflammatory response syndrome: fever or normothermia, shivering, tachycardia, and tachypnea; (3) Deterioration of liver function due to an unknown underlying cause; (4) Hepatic encephalopathy; (5) Shock; (6) Refractory ascites, no response to diuretics, or renal failure; (7) Acute gastrointestinal tract bleeding; (8) One or more of the following laboratory test abnormalities are present: 1) Ascites polymorphonuclear (PMN)cell count >= 0.25*10^9/L; 2) Positive ascites bacteria culture; 3) Procalcitonin (PCT) > 0.5 ng/mL, and infection of other sites is excluded; 4. Patients with bacteascites, which were culture-positive but did not meet the diagnositic criteria of spontaneous bacterial peritonitis. 5. Patients with sterile ascites, which were asymptomatic and normal of ascites laboratory examination.
Exclusion criteria
Exclusion criteria: 1. Associated with acute infection of HAV, HEV, EBV or CMV; 2. Persons with other tissues and organs infection; 3. Ascites caused by other reasons, such as renal ascites and cardiogenic ascites; 4. Pregnancy, drug abuse or HIV infection; 5. Uncontrolled liver cancer or other systemic tumors; 6. Received an organ transplant; 7. Are receiving glucocorticoid or other immunosuppressive therapy; 8. Long-term or recent use of antibacterial drugs, probiotics and related drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total bacterial DNA quantification;Gram-positive bacterial DNA quantification;Gram-negativetive bacterial DNA quantification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Polymorphonuclear, PMN;Bacterial culture; | — |
Countries
China
Contacts
Public ContactZhongjie Hu
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed