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

NCT04711122 | Unknown

• 1 other identifier: 12345678
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/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.

Conditions

Liver Cirrhosis; Upper Gastrointestinal Bleeding

Keywords

Liver cirrhosis; Childscore A

Outcome Measures

Primary Outcomes (1)

• Prophylactic antibiotics in cirrhotic patients.

  Rate 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.

  1 year

Study Arms (1)

Role of prophylactic antibiotics in childscore A

Role of prophylaxis against infections in progression of cirrhotic patients with childscore A

Drug: Third generation cephalosporin antibiotics

Interventions

Third generation cephalosporin antibiotics DRUG

Assessment of antibiotic effect

Role of prophylactic antibiotics in childscore A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cirrhotic patients with childscore A

You may qualify if:

• Child score "A" Cirrhotic patients
• Hematemesis and / or melena.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Related Info

MeSH Terms

Conditions

Liver Cirrhosis; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Hemorrhage

Study Officials

• Nariman Gamal, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nariman Gamal, MD

CONTACT

01005474366; narimangamal11@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: January 15, 2021
• Study Start: December 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: April 30, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-10