Diagnostic of Spontaneous Bacterial Peritonitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01193426
First received: August 31, 2010
Last updated: May 31, 2011
Last verified: August 2010
  Purpose

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 work conducted to exclude the urinary tract infection (Oregioni et al., 2005).

During the preliminary experiments conducted for this project, the investigators also found systematic variation of another marker, leptin. This is a protein hormone involved in the inflammatory and immune responses (Otero et al., 2005). It appears necessary to include the study of this marker in the analysis of differential protein response between patients suffering or not suffering from SBP.

The investigators therefore propose a diagnostic study, non-interventional, prospective, multicenter trial conducted over 2 years.

  • The main objective is to establish the diagnostic performance (sensitivity, specificity, positive predictive value and negative) of IL-8 and IL-6, assayed in the ascites fluid by an automated ELISA in the early diagnosis of SBP.
  • The secondary objectives are to confirm the interest of the measurement of leptin in the SBP and to establish the diagnostic performance of IL-8 and IL-6 or leptin according to different clinical features in patients (score Child-Pugh classification and history of SBP, ascitic fluid infection with positive bacterial culture).

Condition Intervention
Spontaneous Bacterial Peritonitis
Other: Ascite liquid puncture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of IL-6 and IL-8 Interleukin Rates to Diagnose Spontaneous Bacterial Peritonitis

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Interleukin-8 rate [ Time Frame: Every 6 months during 3 years ] [ Designated as safety issue: No ]
  • Interleukin-6 rate [ Time Frame: Every 6 months during 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • leptin rate [ Time Frame: Every 6 months during 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Ascitic fluid obtained by paracentesis


Estimated Enrollment: 500
Study Start Date: September 2010
Estimated Study Completion Date: November 2013
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cirrhosis patient
All consecutive patients with cirrhosis admitted to the five participating center Patients were hospitalized or treated in an ambulatory setting for treatment of ascites or complications of cirrhosis. Ascitic fluid was obtained by paracentesis according to the usual clinical management for these patients.
Other: Ascite liquid puncture
Ascitic fluid obtained by paracentesis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All consecutive patients with cirrhosis admitted to the five participating center Patients were hospitalized or treated in an ambulatory setting for treatment of ascites or complications of cirrhosis.

Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Patient with social insurance
  • Signature of informed consent
  • Patient admitted for treatment of ascites or complications of cirrhosis. Diagnosis of cirrhosis relied on clinical, biological and morphological criteria (portal hypertention, hepatic biopsy…).

Exclusion Criteria:

  • Patient who have received abdominal surgery within the last month.
  • Patient with chylous ascites or ascites not related to portal hypertention (pancreatic ascites, hemoperitoneum, ascites observed during acute heart failure, peritoneal tuberculosis, hepatocellular carcinome…)
  • Patient with obesity severe (IMC ≥ à 35 kg/m2)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193426

Contacts
Contact: LANDRAUD Luce, MD, PhD 0033 4 92 03 62 14 landraud.l@chu-nice.fr

Locations
France
Hepato-gastro-enterology and bacteriology department Recruiting
Brest, France, 29609
Contact: NOUSBAUM Jean Baptiste, PU PH    0033 2 98 34 71 48    jean-baptiste.nousbaum@chu-brest.fr   
Principal Investigator: NOUSBAUM Jean Baptiste, PU PH         
Principal Investigator: PAYAN Christopher, PU PH         
Hepato-gastro-enterology and Bacteriology department Recruiting
Creil, France
Contact: CADRANEL Jean François, PhD    0033 3 44 61 64 43    jfrancois.cadranel@ch-creil.fr   
Principal Investigator: CADRANEL Jean François, PhD         
Hepato-gastro-enterology and Bacteriology department Recruiting
Hyères, France, 83400
Contact: RENOU Christophe, PhD    0033 4 94 00 27 08    crenou@ch-hyeres.fr   
Principal Investigator: RENOU Christophe, PhD         
Principal Investigator: RAOULT Annie, PhD         
Hepato-gastro-enterology and Bacteriology department Recruiting
Montpellier, France, 34295
Contact: PAGEAUX Georges, PU PH    0033 4 67 33 70 81    gp-pageaux@chu-montpellier.fr   
Principal Investigator: PAGEAUX Georges, PU PH         
Principal Investigator: VANDE PERRE Philippe, PU PH         
Hepato-gastro-enterology and Bacteriology department Recruiting
Nice, France, 06000
Contact: LANDRAUD Luce, MD,PhD    0033 4 92 03 62 14    landraud.l@chu-nice.fr   
Principal Investigator: LANDRAUD Luce, MD, PhD         
Sub-Investigator: TRAN Albert, PU PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Study Director: LANDRAUD Luce, MD, PhD CHU de Nice
  More Information

No publications provided

Responsible Party: Dr. Luce LANDRAUD, Bacteriology department
ClinicalTrials.gov Identifier: NCT01193426     History of Changes
Other Study ID Numbers: 10-API-01
Study First Received: August 31, 2010
Last Updated: May 31, 2011
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Centre Hospitalier Universitaire de Nice:
Hepatic
cirrhosis
IL-6
IL-8
Leptine

Additional relevant MeSH terms:
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014