Clinical Trial: Diagnostic of Spontaneous Bacterial Peritonitis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Evaluation of IL-6 and IL-8 Interleukin Rates to Diagnose Spontaneous Bacterial Peritonitis
Brief Summary:
Spontaneous bacterial peritonitis (SBP), an infection of ascitic fluid in the absence of localized intra-abdominal infection, is one of the main potentially fatal complications of cirrhosis. In the case of SBP, early diagnosis and rapid therapeutic care can improve patient survival (Garcia-Tsao, 2001).
The diagnosis of SBP is based on the detection of a polymorphonuclear neutrophils count equal to or greater than 250 /mm3 in the ascitic fluid (method of reference). However, obtaining an ascitic cell count is sometimes difficult because it can not always be performed in emergency especially outside the opening hours of the laboratory of Bacteriology. This raises the necessity of developing quick and easy alternative approaches of diagnosis.
Few groups have proposed the use of urinary reagent strip for rapid diagnosis of SBP. Nevertheless, the investigators clinical teams have shown that the sensitivity of this test was low in a large national multicenter prospective study involving more than a thousand patients (Nousbaum et al., 2007). The use of Multistix strips test is thus not recommended for the routine application of diagnosis of SBP due to its lack of sensitivity.
Although performed on small groups of patients, several studies have reported that IL-8 or IL-6 might be used as markers of ascitic fluid infections. Based on these data and confirmed by the investigators preliminary results the investigators propose to study on a broad recruitment of patients estimated to about 500 inclusions (about 45 infected patients) the interest of using IL-8 and IL-6 as predictive markers of SBP. The investigators propose to use an ELISA method, standardized, rapid and automated, applicable in the context of emergency (7 days a week and 24 hours a day) as previously described in the wo
Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Nice
Current Primary Outcome:
- Interleukin-8 rate [ Time Frame: Every 6 months during 3 years ]
- Interleukin-6 rate [ Time Frame: Every 6 months during 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: leptin rate [ Time Frame: Every 6 months during 3 years ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire de Nice
Dates:
Date Received: August 31, 2010
Date Started: September 2010
Date Completion: November 2013
Last Updated: May 31, 2011
Last Verified: August 2010
