Impact of Nonselective Beta-blocker on Acute Kidney Injury in Cirrhotic Patients With Esophageal Varices
Impact of Nonselective Beta-blocker on Acute Kidney Injury in Cirrhotic Patients With Esophageal Varices
We will include patients with EV and EVB. They will be randomized to EVL vs. NSBB for primary
 prevention And EVL+long-term NSBB vs. EVL+short-term NSBB for secondary prevention. 150
 patients will be included in a 3-year period. Primary end-points are formation/progression of
 ascites, acute kidney injury and survival. The other outcomes such as bleeding, rebleeding,
 infection and other risk factors will be also analyzed.
Despite advance in the prevention and treatment of esophageal variceal bleeding (EVB), it is
 still a majorcomplication of portal hypertension with the characteristic of a high mortality
 around 15~20% after anepisode of hemorrhage. Following development of EV and EVB, ascites and
 renal dysfunction occurs in a large portion of patients with time. The international
 consensus suggested use of non-selective beta-blocker(NSBB) to prevent EVB. Long-term use of
 NSBB was also found to decrease occurrence of encephalopathy and spontaneous bacterial
 peritonitis (SBP) and extend survival. Until 2010, Dr. Lebrec et al. found use of NSBB might
 decrease survival in cirrhotic patients with refractory ascites, therefore they suggested
 discontinued use of NSBB in these patients. The findings lead to a vigorous dispute between
 hepatologists. In 2011, the reputable team again found use of NSBB might cause
 post-paracentesis circulatory dysfunction (PPCD) in cirrhotic patients undergoing a large
 volume paracentesis. Occurrence of PPCD was known to cause acute kidney injury (AKI) and
 increase mortality. In 2014, Austria investigators found use of NSBB was associated with
 increased AKI and shortened survival in patients with SBP. Despite the findings of these
 studies implicated the harmful aspects of NSBB use, a major debate remained because lack of
 randomized controlled trial some unequal distribution of patients.Taipei Veterans General
 Hospital is renowned by its high profile research in portal hypertension and its related
 complications. The current proposal is aimed to clarify the strategy of NSBB use. We will
 include patients with EV and EVB. They will be randomized to EVL vs. NSBB for primary
 prevention And EVL+long-term NSBB vs. EVL+short-term NSBB for secondary prevention. 150
 patients will be included in a 3-year period. Primary end-points are formation/progression of
 ascites, acute kidney injury and survival. The other outcomes such as bleeding, rebleeding,
 infection and other risk factors will be also analyzed.
Criteria

 Inclusion Criteria:

 Age of 20 to 85 years

 Cirrhotic patients with esophageal varices regardless of bleeding event or not will be
 enrolled in this study.

 Exclusion Criteria:

 Terminal stage HCC/ other malignancy/ Stroke or active sepsis/ Chronic kidney disease stage
 4 under renal replacement therapy/ Contraindications to non-selective beta-blockers/ A
 history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular
 intrahepatic porto-systemic shunt, or shunt surgery/ Serum total bilirubin >10 mg/dL/
 Refractory ascites/ Hepato-renal syndrome/ Pregnancy/ Severe heart failure (NYHA Fc
 III/IV)/ Bronchial asthma or chronic obstructive pulmonary disease/ Second or third degree
 atrioventricular block/ Severe hypotension/ Refusal to participate