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Status unknownNCT04711122Updated Oct 28, 2022

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

An observational study in Liver Cirrhosis and Upper Gastrointestinal Bleeding, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2022-10-28.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Cirrhosis
  • Upper Gastrointestinal Bleeding

Keywords

  • Liver cirrhosis
  • Childscore A
03

In context

Peritonitis

185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.

This study's planned enrollment of 80 is below the median of 127 across 59 observational studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Cirrhotic patients with childscore A

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugThird generation cephalosporin antibiotics

    Assessment of antibiotic effect

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

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References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04711122
Lead sponsor
Assiut University
Responsible party
Nariman Gamal Abd Elhakeem (Principal investigator, Assiut University) — Principal investigator
First posted
Jan 15, 2021
Start date
Dec 1, 2022 (estimated)
Primary completion
Feb 28, 2023 (estimated)
Completion
Apr 30, 2023 (estimated)
Last update
Oct 28, 2022

Study contacts

Nariman Gamal, MD
Contact
narimangamal11@gmail.com
01005474366
Nariman Gamal, MD
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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