Progressive AKI and 28-day survival in patients with cirrhosis and spontaneous bacterial peritonitis on beta blockers-a prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- To study the frequency of progressive AKI and 28-day survival in those patients with cirrhosis and spontaneous bacterial peritonitis, who are receiving beta blockers.
研究概览
简要总结
Non-selective beta blockers (NSBB), when administered to patients with cirrhosis, lower portal pressure and significantly reduce the risk of esophageal variceal bleeding. They also prevent the development of ascites in patients with compensated cirrhosis and clinically significant portal hypertension. However, their role in spontaneous bacterial peritonitis (SBP) is controversial.
SBP is associated with reduced effective arterial blood volume; thus, 33 to 43 percent of patients with SBP have acute kidney injury at presentation. Mortality is six times higher in patients with SBP with AKI compared to those without AKI. Twelve percent of patients with SBP had progressive AKI within 48hr after diagnosis. High serum creatinine levels before SBP diagnosis and infection resolution are independent predictors of renal impairment. In patients with SBP and mean arterial blood pressure (MAP) <65 mmHg, treatment with NSBB is associated with renal impairment.
To the best of our knowledge, there is a deficit in the literature on the frequency of progressive AKI in patients with SBP who were receiving beta blockers. Studies were retrospective, with conflicting results regarding the effect of NSBB on the risk of progressive AKI and 28-day survival in patients with SBP and MAP >65 mm Hg. Hence, we are planning a prospective study to answer these questions.
The primary purpose is to study the frequency of progressive AKI and 28-day survival in those patients with cirrhosis and spontaneous bacterial peritonitis, who are receiving beta blockers.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria for group1: Patients with cirrhosis and spontaneous bacterial peritonitis who were on propranolol, admitted in the wards of Medical Gastroenterology and Medicine during the study period.
- •Inclusion criteria for group2: Patients with cirrhosis and spontaneous bacterial peritonitis who were not on propranolol, admitted in the wards of Medical Gastroenterology and Medicine during the study period.
排除标准
- •Patients who already received antibiotic within 7days of diagnosis of SBP Variceal bleed within 7days of diagnosis of SBP Chronic kidney disease Intrinsic renal disease Refractory ascites Hepatocellular carcinoma Peritoneal carcinomatosis Peritoneal tuberculosis Pancreatitis Bleeding into ascitic fluid Heart Failure Concurrent other malignancies Human immunodeficiency virus infection Use of immunosuppressive agents.
结局指标
主要结局
To study the frequency of progressive AKI and 28-day survival in those patients with cirrhosis and spontaneous bacterial peritonitis, who are receiving beta blockers.
时间窗: 2,7 and 28days
次要结局
- To compare the frequency of progressive AKI and 28-day survival in patients with cirrhosis and spontaneous bacterial peritonitis on beta-blockers when compared to controls.(2,7 and 28days)
研究者
Siva Krishna Sirasapalli
JIPMER, Pondicherry