Rapid Diagnosis of Spontaneous Infection of Ascitic Fluid Clinical Trial
Official title:
The Ratio of Ascites Calprotectin to Total Protein is a Diagnostic and Prognostic Marker for Spontaneous Bacterial Peritonitis in Liver Cirrhosis
The prognosis of spontaneous bacterial peritonitis (ISLA) remains a serious complication of cirrhosis. Rapid diagnosis of ISLA is a key issue for improving the prognosis. The determination of calprotectin in ascites, used for the diagnosis of infection of ascitic liquid, could allow the diagnosis in a very short time (about 30 minutes). To date, the determination of calprotectin in ascites was not evaluated properly. The investigators would thus evaluate the interest of the determination of calprotectin in ascites for the rapid diagnosis of ISLA in cirrhotic patients, like you, hospitalized for decompensation of their disease. The main purpose of this pilot study will determine the optimal threshold calprotectin in ascites for diagnosis of ISLA.
The occurrence of ascites in cirrhotic patients is a frequent event (about half of these
patients developed ascites after 10 years of evolution) and marks an evolutionary turning
point in the natural history of cirrhosis (30% survival at 5).
The spontaneous bacterial peritonitis (ISLA) is the leading infectious complication cirrhotic
patient (prevalence of 10-30%). Half of these ISLA are already present on admission of the
patient and over 20% of these infections are totally asymptomatic. The delay processing of
ISLA causes heavy mortality. Even when antibiotic treatment is started immediately after the
diagnosis of ISLA, in-hospital mortality remains high (about 20%) and mainly related to the
development of severe sepsis, septic shock and hepatorenal syndrome; the medium-term
prognosis remains severe as also survival after an episode of ISLA is 30-50% at 1 year.
Therefore, the surviving patients with a first episode of ISLA are candidates for liver
transplantation. Given the major prognostic implications and the asymptomatic nature of these
infections, examination of ascites with neutrophil count (ANC) and bacteriological cultures
still recommended during any puncture, which increases support. This is why clinicians are
sensitive to processes that simplify the diagnosis of ISLA or make it faster.
The measurement of calprotectin in ascites could be of major interest for the rapid diagnosis
of ISLA. It is a glycoprotein of 36 KDa fixing calcium and zinc, synthesized by neutrophils
(where it represents 60% of the soluble proteins from the cytosol) as well as monocytes and
macrophages in the lower concentration. It has anti-bacterial and anti-fungal,
immunomodulatory and pro-apoptotic. Its synthesis is increased in case of inflammation and
its rate reflects, in inflammatory bowel disease, the severity of the inflammation of the
bowel wall. Fecal calprotectin allows to discriminate inflammatory bowel disease (IBD)
functional impairment of the gastrointestinal tract (irritable bowel syndrome) in symptomatic
patients and also seems more powerful than other non-specific markers of inflammation (CRP,
sedimentation rate, leukocytosis) to make this distinction; again, this biological marker
allows therapeutic monitoring for patients with IBD.
The reference technique proposed by the laboratory for assaying BÜHLMANN calprotectin is a
quantitative ELISA in a stool sample or ascites but the Quantum Blue® Reader offers a faster
quantitative measure (in 12 minutes). It consists of a sandwich immunoassay including the
speed could be advantageously used for the diagnosis of ISLA. However, few studies have
evaluated the assay of plasma calprotectin or in ascites in cirrhotic patients. A high plasma
concentration of calprotectin could have a prognostic value in alcoholic cirrhosis, as a high
concentration of calprotectin in ascites in decompensated cirrhosis.
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