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Prophylactic Antibiotics in Prevention of Spontaneous Bacterial Peritonitis in Compensated Liver Cirrhosis

The Role of Prophylactic Antibiotics in Prevention of Spontaneous Bacterial Peritonitis in Compensated Liver Cirrhosis With Upper Gastrointestinal Bleeding

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04711122
Enrollment
80
Registered
2021-01-15
Start date
2022-12-01
Completion date
2023-04-30
Last updated
2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Upper Gastrointestinal Bleeding

Keywords

Liver cirrhosis, Childscore A

Brief summary

timely short-term antibiotic prophylaxis is an essential step in the management of these patients . Prophylaxis must be instituted as early as variceal hemorrhage is suspected, and timely administration has been associated with a reduced re-bleeding rate and lower mortality . More recently, the American Association for the Study of Liver Diseases (AASLD), the Department of Veterans Affairs (VA), and the American Society for Gastrointestinal Endoscopy (ASGE) recommended antibiotic prophylaxis in all cirrhotic patients with UGIB, regardless of its source (i.e. variceal or non-variceal) or the presence of ascites.

Detailed description

cute variceal bleeding is one of the major causes of death in cirrhotic patients . It is also the major cause of upper gastrointestinal (GI) bleeding in cirrhotic patients, accounting for 70% of cases . Mortality during the first episode is estimated to 15-20% but is higher in severe patients (Child Pugh C), at around 30%, whereas it is very low in patients with compensated cirrhosis (Child Pugh A). Hemorrhage from gastro-esophageal varices is a devastating complication of portal hypertension. Although the in-hospital mortality of acute variceal bleeding was up to 40% about 20 years ago, it was decreased to about 15-20% in recent years.20 One of the main reasons in the decrease of mortality has been ascribed to the alertness of clinicians in the treatment and prophylaxis of associated bacterial infections. The prevalence of bacterial infections in cirrhotic patients with gastrointestinal hemorrhage has been up to 52%-66%. Therefore, timely short-term antibiotic prophylaxis is an essential step in the management of these patients. Prophylaxis must be instituted as early as variceal hemorrhage is suspected, and timely administration has been associated with a reduced re-bleeding rate and lower mortality . More recently, the American Association for the Study of Liver Diseases (AASLD), the Department of Veterans Affairs (VA), and the American Society for Gastrointestinal Endoscopy (ASGE) recommended antibiotic prophylaxis in all cirrhotic patients with UGIB, regardless of its source (i.e. variceal or non-variceal) or the presence of ascites. The importance of prophylaxis is incontrovertible in patients with advanced cirrhosis, whereas in patients with less severe disease, conflicting data have been published. In a retrospective study, Child A patients had a low rate of bacterial infection (2%) in the absence of antibiotic prophylaxis, and there was no difference in mortality between patients on and off antibiotics . In contrast, antibiotics were associated with a marked mortality reduction in Child C patients. However, more prospective studies are needed to assess whether antibiotic prophylaxis can be avoided in Child A patients . Thus, this study will be conducted to investigate the necessity of prophylactic antibiotic in compensated cirrhotic patients with UGIB and to evaluate its influence on patient outcomes.

Interventions

DRUGThird generation cephalosporin antibiotics

Assessment of antibiotic effect

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Child score A Cirrhotic patients * Hematemesis and / or melena.

Exclusion criteria

* Patient with unsuccessful endoscopic hemostasis * Patients who already have signs of infections (elevation in the body temperature, elevation in white blood cells above 10,000 cell/mmᵌ); * Patients with occult infection (defined as positive blood cultures obtained before antibiotic prophylaxis) * Patients using antibiotics before endoscopy. * Patients refuse to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Prophylactic antibiotics in cirrhotic patients.1 yearRate of infection in patients using prophylactic antibiotics in Child A cirrhotic patients presented with upper gastrointestinal bleeding according to blood culture and chest x ray.

Contacts

Primary ContactNariman Gamal, MD
narimangamal11@gmail.com01005474366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026