Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04711122 |
| Other study ID # |
12345678 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Assiut University |
| Contact |
Nariman Gamal, MD |
| Phone |
01005474366 |
| Email |
narimangamal11[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
