K74 R65
Conditions
Interventions
Group 1: Multicenter Arm: Inclusion of patients with liver cirrhosis, ascites, and signs of infection. Analysis of blood and ascites for bacterial DNA, markers of inflammation and endotoxemia, and gen
Sponsors
Universitätsklinikum Jena,
Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen
Center for Sepsis Control and Care (CSCC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - In-hospital mortality with respect to bacterial DNA result - 12-month mortailty with respect to bacterial DNA result - Correlation of bacterial DNA with markers of inflammation and endotoxemia, stage of liver disease, comorbidities, medical procedures, and genetic risk alleles of innate immunity - Diagnostic sensitivity of multiplex PCR for the detection of pathogens in spontaneous bacterial peritonitis | — |
Countries
Germany
Contacts
Public ContactTony Bruns
Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie Universitätsklinikum Jena
Outcome results
None listed