The aim of the study is to improve the diagnostic tools of spontaneous bacterial peritonitis.The primary aim is to evaluate the use of dipsticks as bedside diagnostics compared to the current standard polymorphonuclear leukocyte count in identifying…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the study:
- validity of the dipstick
Secondary outcome
Secundary outcomes of the study:
- validity of the culture methods used
- detected micro-organisms
- occurence of bacterial translocation
- development of SBP.
Background summary
Ascites is in patients with cirrhosis of the liver the most common
complication. The occurrence of an infection of ascitic fluid, spontaneous
bacterial peritonitis (SBP), is associated with high morbidity and mortality.
Early and adequate recognition of the infection makes it possible to start
antibiotic treatment at an early stage, thereby preventing associated
complications.
The current diagnostic tools have 2 downsides. First, the current standard for
determining infection in ascitic fluid is the polymorphonuclear leukocyte
count. This is determined in the laboratory and often takes a long time before
results become available, especially during after-office hours, causing a delay
in treatment. The use of dipstick-tests as bedside diagnostics of SBP can be a
good alternative for the rapid detection of infection.
The second shortcoming of the current diagnostics for SBP concerns the culture
method. Samples of all diagnostic and therapeutic paracenteses performed are
inoculated in blood culture bottles to detect the (possible) presence of a
causative micro-organism. In 60% of all ascitic fluid cultures in which an
infection is present, no micro-organism is currently identified. This makes it
impossible to adjust the antibiotic treatment for the causative micro-organism.
Study objective
The aim of the study is to improve the diagnostic tools of spontaneous
bacterial peritonitis.
The primary aim is to evaluate the use of dipsticks as bedside diagnostics
compared to the current standard polymorphonuclear leukocyte count in
identifying an infection in ascitic fluid.
The secondary aim is to compare the current standard of ascitic fluid culture,
i.e. blood culture bottles, to other different microbiological methods in the
detection of micro-organism(s) present.
Study design
single-center prospective study
All patients with cirrhosis of the liver and ascites admitted to the ward of
gastroenterology and hepatology of the Erasmus Medical Center and who require
either a diagnostic or therapeutic paracentesis are asked to participate in the
study.
Ascites of patients who are included in the study will be screened for
infection by use of a dipstick test next to the standard polymorphonuclear
leukocyte count.
Next to the standard ascitic fluid culture, ascites will undergo different
microbiological methods, i.e inoculation of larger volume of ascites, special
culture for fungi, for the detection of micro-organisms. In those cases where
no micro-organism is identified, a PCR is used to detect bacterial DNA.
Study burden and risks
No extra burden or risk for the patient is associated with this study since
samples are obtained during standard treatment procedures. Ascitic fluid is
obtained from a paracentesis performed for general treatment. Blood sample is
obtained when blood is drawn for general laboratory diagnostics. No extra vena
punction is necessary.
Dr Molewaterplein 40
3015 GD Rotterdam
Nederland
Dr Molewaterplein 40
3015 GD Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
- cirrhosis of the liver and ascites requiring therapeutic or diagnostic paracentesis
- age > 18 years
- informed consent
Exclusion criteria
-
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL11639.078.06 |