Characteristics and Management of Acute Kidney Injury in Hospitalized Patients With Cirrhosis: a Multicenter Intercontinental Observational Prospective Study: The International Club of Ascites GLOBAL AKI Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,456
- 试验地点
- 38
- 主要终点
- 90-day Mortality
研究概览
简要总结
The aims of this study will be to identify the clinical characteristics, the management and the outcomes of acute kidney injury in patients with cirrhosis worldwide.
Specific aims:
- To establish the severity of AKI across different regions
- To identify precipitants of AKI across different centers
- To identify the phenotypes of AKI across different centers
- To evaluate differences in the management of AKI across different centers and their impact on clinical outcomes
- To assess outcomes of acute kidney injury (resolution of AKI, in-hospital mortality, 28-day mortality, 90-day mortality)
详细描述
Each center will then include patients with cirrhosis who are admitted to the hospital with AKI upon admission or who develop AKI during the hospital stay, and who provide signed informed consent.
Acute kidney injury will be defined according to the International Club of Ascites Acute Kidney Injury criteria The following precipitating events of AKI will be considered: volume loss/excessive diuretic use, spontaneous bacterial peritonitis (SBP), non-SBP infection, gastrointestinal bleeding, nephrotoxic drugs (including nonsteroidal anti-inflammatory drugs, contrast media), other causes and no identifiable precipitant.
AKI will be classified in the following phenotypes:
- Hypovolemia-induced AKI: history of excessive fluid losses (i.e., excessive diuresis due to diuretic therapy with loss of body weight >500 g/day or 1,000 g/day in patients without and with edema, respectively; severe diarrhea) or bleeding the days before AKI and improving with fluid administration.
- HRS-AKI: all the following should be present: a) ascites; b) lack of regression of AKI to a lower stage or resolution of AKI after 2 days of diuretic withdrawal and volume expansion with albumin (1 g/kg of body weight per day to a maximum of 100 g/day); c) absence of shock; d) no current or recent treatment with nephrotoxic drugs; d) absence of parenchymal disease as indicated by proteinuria >500 mg/day, microhaematuria (>50 red blood cells per high power field), urinary injury biomarkers (if available) and/or abnormal renal ultrasonography.
Patients will be followed from admission until liver transplantation, death or 90 days, whichever occurs first. Data collected will include demographic, clinical and biochemical information, such as AKI severity, phenotype and evolution. There will be particular emphasis on collecting data regarding the initial management of AKI occurring in the first 2 to 3 days. Furthermore, basic demographic and disease information will be collected in hospitalized patients with cirrhosis who do not develop AKI during the stay to determine the true burden of AKI in this patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a) Patients with cirrhosis admitted to hospital for the treatment of a complication of liver disease (ascites, gastrointestinal bleeding, hepatic encephalopathy, bacterial infections, jaundice, etc)
排除标准
- •Age < 18 years old;
- •Hepatocellular carcinoma outside Milan criteria (i.e., a single lesion <5 cm or multiple lesions [maximum of three], the largest of which measures ≤ 3 cm);
- •Extrahepatic malignancy other than non-melanoma skin cancer within last 5 years;
- •Previously known severe extrahepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe congestive heart disease [NYHA class ≥ 3]; severe chronic obstructive pulmonary disease [GOLD class ≥ 3], psychiatric disorders);
- •Previous solid organ transplantation;
- •HIV infection with CD4 ≤ 250/µL;
- •Patients who cannot provide prior informed consent and no legal surrogate decision maker
结局指标
主要结局
90-day Mortality
时间窗: 90 days
Mortality at 90 days
次要结局
- 28-day mortality(28 days)
- Progression of AKI(Hospital stay (up to 90 days))
- Staging of acute kidney injury across geographic areas(Hospital stay (up to 90 days))
- Resolution of AKI(Hospital stay (up to 90 days))
- Phenotypes of acute kidney injury across geographic areas(Hospital stay (up to 90 days))
- Adherence to the International Club of Ascites recommendations for the management of AKI(Hospital stay (up to 90 days))
- In-hospital mortality(Hospital stay (up to 90 days))
- Development of CKD(90 days)
研究者
Salvatore Piano
Assistant Professor of Medicine
Azienda Ospedaliera di Padova