A Retrospective Analysis of Outcomes in Patients With Hepatorenal Syndrome at Methodist Dallas Medical Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Primary Outcome for HRS-AKI patients
研究概览
简要总结
Hepatorenal syndrome (HRS) is a common cause of acute kidney injury (AKI) in patients with liver disease [1]. Increased activity and presence of vasodilators such as nitric oxide in cirrhotic patients leads to vasodilation, especially in the splanchnic circulation, resulting in hemodynamic changes that precipitate renal injury [1]. Patients may present with elevated serum creatinine (Cr), benign urine sediment, and low urine sodium [1].
详细描述
There are two main classifications of HRS: HRS-AKI (previously known as type 1 HRS) and diuretic-resistant ascites (previously known as type 2 HRS) [1].
The ultimate treatment for patients with HRS is to improve hepatic function via treatment of underlying etiology or liver transplantation; however, this is not always immediately possible due to the high demand for liver transplantation among other factors [1]. Continuous renal replacement therapy (CRRT) can also be considered, especially in patients with severe electrolyte derangements such as hypokalemia or pulmonary edema, that are not responding to medical therapy [1]. Often, CRRT is used as a bridging therapy to stabilize patients until they are optimized for receiving a liver transplant [1, 2]. CRRT, however, comes with its own risks and disadvantages such as hypotension and increased risk of cardiac adverse events [2]. In certain cases, transjugular intrahepatic portosystemic shunts (TIPS) can benefit patients with HRS by reducing portal pressure resulting in increase in renal perfusion [1].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients >18 years old that were hospitalized between April 1st 2019 and April 1st 2023 who either presented with HRS-AKI or developed a diagnosis of HRS during the hospital course. HRS-AKI will be defined based on the ICA criteria, described below:
- •Presence of cirrhosis, acute liver failure, or acute-on-chronic liver failure
- •An increase in serum Cr of ≥0.3 mg/dL within 48 hours or ≥50% from baseline value and/or urinary output ≤0.5 mL/kg of body weight for ≥6 hours (requires use of a urinary catheter)
- •No full or partial response for ≥2 days of diuretic withdrawal and volume expansion with albumin (dosed at 1 g/kg of body weight/day)
- •Absence of shock
- •No current or recent treatment with nephrotoxic drugs
- •Absence of parenchymal renal disease
- •Suggestion of renal vasoconstriction based on FENa <0.2%
排除标准
- •1. HRS-AKI patients <18 years of age
- •All patients hospitalized between April 1st 2019 and April 1st 2023 without a diagnosis of HRS-AKI.
结局指标
主要结局
Primary Outcome for HRS-AKI patients
时间窗: 4 years
Mortality rates, morbidities, complications, and other clinically relevant outcomes in HRS-AKI patients
次要结局
- post transplant mortality rates(4 years)