Prognostic and Diagnostic Relevance of Bacterial DNA Detection in Patients with Liver Cirrhosis and Ascites at Risk for Spontaneous Bacterial Peritonitis (ACTION) - a prospective multicenter Study

• Conditions: K74; R65; Fibrosis and cirrhosis of liver; Systemic Inflammatory Response Syndrome [SIRS]

• Registration Number: DRKS00000631
• Lead Sponsor: niversitätsklinikum Jena,Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen Center for Sepsis Control and Care (CSCC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-03
• Study Completion: 2012-12-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Liver cirrhosis defined by clinical, analytical, or histological criteria.
2. Presence of ascites accessible to diagnostic abdominal paracentesis.
3. Age =18 Jahre
4. Written informed consent
5. For multicenter arm at least one of the following criteria a. or b.:
a. At least 2 fulfilled criteria of systemic inflammatory response syndrome (SIRS) within the last 24 hours: [i] Body temperature <36 °C or =38 °C, [ii] Heart rate =90 beats per minute, [iii] Respiratory rate >20 breaths per minute or a PaCO2 less than 32 mm Hg (4.3 kPa), [iv] White blood cell count =4,000/mm³ (Leukopenia) or >12,000/mm³ (Leukozytosis) or greater than 10% immature band forms.
b. Bacterial infection within the last 14 days with at least one of the following criteria fulfilled: [i] Positive blood culture result (Septicemia), [ii] Positive urinary culture or leukocyturia =20 per high power field (Urinary tract infection), [iii] Pulmonary infiltrates on chest X-ray or CT scan (Pneumonia), [iv] Inflammatory skin lesion (Skin infection), [v] PMN count in ascitic fluid =250 /µl (Spontaneous bacterial peritonitis), or [vi] other bacterial infection according to clinical, microbiological, or imaging criteria (e.g. cholangitis)

Exclusion Criteria

1. Peritoneal carcinomatosis.
2. Secondary peritonitis, i.e. surgically treatable intra-abdominal source of infection including postoperative peritonitis after abdominal surgery.
3. Acute pancreatitis.
4. Tuberculous peritonitis.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90-day mortality of hospitalized patients with liver cirrhosis, ascites, and signs of infection with respect to positive bacterial DNA result in ascitic fluid and in blood

Secondary Outcome Measures

Name	Time	Method
-­ In-hospital mortality with respect to bacterial DNA result<br>-­ 12-month mortailty with respect to bacterial DNA result<br>- Correlation of bacterial DNA with markers of inflammation and endotoxemia, stage of liver disease, comorbidities, medical procedures, and genetic risk alleles of innate immunity<br>-­ Diagnostic sensitivity of multiplex PCR for the detection of pathogens in spontaneous bacterial peritonitis