Clinical Trials Logo

Clinical Trial Summary

Spontaneous bacterial peritonitis is defined as the presence of an infection in a previously sterile ascites in the absence of an intra-abdominal source of infection or malignancy . The variants of Spontaneous bacterial peritonitis includes - (i) Classic Spontaneous bacterial peritonitis: -ascitic fluid polymorphonuclear leukocyte counts more than 250/mm3 and positive culture. (ii) Culture negative neutrocytic ascitis but the ascitic fluid polymorphonuclear leukocyte counts more than 250/mm3 and (iii) Bacterascites: - a culture positive ascitic fluid but the polymorphonuclear leukocyte counts less than 250/mm3


Clinical Trial Description

Spontaneous bacterial peritonitis is a serious complication in patient with decompensated liver cirrhosis . The incidence in ascetic patients varies between 7-30 % as a consequence result of impaired defense mechanism and increased susceptibility to bacterial infection in cirrhotic patients with ascites Spontaneous bacterial peritonitis may complicated by hepatorenal syndrome or systemic sepsis and has high recurrence rate - estimated as approximately 70% within 1 year of follow up . The clinical detection of spontaneous bacterial peritonitis requires a high index of suspicion because symptoms and signs of infection are obscure in most of patients. About 13% of patients are asymptomatic and a few studies reported the incidence of asymptomatic spontaneous bacterial peritonitis in cirrhotic patients with ascites The most common clinical manifestations defined by Jeffries et al and Castellote et al in 2007 are: temperature above 38 °C or below 36.5 °C, chills, abdominal tenderness suggestive of peritonitis, developing or worsening hepatic encephalopathy, acute renal failure (defined by an increase in the serum creatinine level to above 133 μmol/L) and arterial hypotension (systolic arterial pressure below 80 mmHg). The American Association for the Study of Liver Diseases recommends performing exploratory paracentesis in each patient with cirrhosis and ascites . A study was done in Poland in 2011, shows the prevalence of spontaneous bacterial peritonitis in asymptomatic inpatients with decompensated liver cirrhosis and found that two of 37 asymptomatic cirrhotics who were included in the study met criteria of asymptomatic spontaneous bacterial peritonitis (5%) . A french study was done in 2013 in asymptomatic cirrhotic outpatients and found that the incidence of asymptomatic Spontaneous bacterial peritonitis was only 1.2% . Another study was done in Pakistan in 2015 and found that the incidence of asymptomatic spontaneous bacterial peritonitis in outpatient patient with cirrhosis was 10%(8 out of 80). Another Egyptian study was done in 2016 on asymptomatic spontaneous bacterial peritonitis in adult Egyptian patient with decompensated cirrhosis and found that 21 (13%) patient was asymptomatic spontaneous bacterial peritonitis out of 160 cirrhotic patient ascetic patient who fulfill the inclusion criteria . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03163745
Study type Observational
Source Assiut University
Contact
Status Completed
Phase
Start date March 11, 2019
Completion date May 26, 2020

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06026267 - Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis N/A
Withdrawn NCT02552862 - Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP) Phase 3
Completed NCT02528097 - A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis N/A
Completed NCT01193426 - Diagnostic of Spontaneous Bacterial Peritonitis
Completed NCT00359853 - Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis Phase 4
Active, not recruiting NCT04159870 - Rifaximin Versus Norfloxacin in Spontaneous Bacterial Peritonitis Phase 3
Completed NCT04153604 - Doxycycline for the Prevention of Spontaneous Bacterial Peritonitis
Completed NCT06234046 - Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin Phase 3
Recruiting NCT01598870 - Diagnosis of Spontaneous Bacterial Peritonitis N/A
Recruiting NCT00761098 - Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (SBP) Phase 4
Completed NCT05401721 - Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
Completed NCT02468089 - To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis N/A
Not yet recruiting NCT04746937 - Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis Phase 3
Recruiting NCT02759497 - Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis N/A
Completed NCT02608658 - Evaluation of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Decompensated Cirrhosis With Ascites N/A
Completed NCT02388035 - Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis N/A
Completed NCT04273373 - Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis. N/A
Active, not recruiting NCT04395365 - Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis Phase 3
Terminated NCT00570960 - Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis Phase 4
Recruiting NCT05422118 - Ascitic Fluid Calprotectin as an Accurate Diagnostic Marker for Spontaneous Bacterial Peritonitis N/A