NCT07794787招募中不适用
To Develop and Validate an Equation for Determination of Major Adverse Kidney Events in Patients With Decompensated Cirrhosis and Ascites- A Prospective Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Major Adverse Kidney Events at 1 year.
研究概览
简要总结
Acute kidney injury (AKI) is the sudden loss of kidney function that occurs frequently in hospitalised patients with cirrhosis.
- It develops in up to 53% and is independently associated with high short-term mortality.
- A diagnosis of AKI (even stage 1 AKI) has been shown to be associated with an increased risk of long-term mortality at 30-day, 90-day and 1-year, compared to patients without AKI, even when there is recovery of AKI.
- Risk factors with the strongest association for developing AKI include CKD, sepsis, spontaneous bacterial peritonitis (SBP), and presence of ascites.
- AKI in cirrhosis is also associated with development of de-novo chronic kidney disease (CKD) , progressive loss of kidney function in patients with pre-existing CKD,recurrent AKI (i.e., AKI on top of CKD) and other organ failures
- Kidney dysfunction in patients with cirrhosis is associated with a marked increase in mortality compared with patients without kidney dysfunction.
- The accurate estimation of kidney function in patients with cirrhosis is hence crucial for prognosis, treatment strategies, and decisions regarding simultaneous liver-kidney transplantation (SLKT).
- Although measured GFR(mGFR) may be ideal for assessing kidney function, it is costly, time-consuming, and challenging to perform frequently in fluctuating kidney function. Therefore, GFR is most commonly estimated using serum creatinine (sCr)-based or cystatin C (CysC)-based equations
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of cirrhosis with ascites with stable renal functions in last 7 days (variability in gfr < 15 % and no AKI).
排除标准
- •Patients with age <18 or more than 65 years
- •Obstructive uropathy or intrinsic kidney disease
- •Patients with multiorgan failure or requiring mechanical ventilation
- •Patients who had previously undergone Liver or Kidney transplant
- •Patients with missing laboratory measurements within 24 hours of admission
- •Lack of baseline serum creatinine
- •Need of renal replacement therapy
- •Severe comorbid cardiopulmonary diseases or extrahepatic malignancy
研究组 & 干预措施
Cirrhosis with ascites
Patients with cirrhosis and ascites admitted in ILBS.
结局指标
主要结局
Major Adverse Kidney Events at 1 year.
时间窗: 1 year
Make is defined as the composite outcome of ≥25% decline in estimated-glomerular-filtration-rate (eGFR) compared with baseline with the development of de-novo chronic-kidney-disease (CKD) stage ≥3 or CKD progression (≥50% reduction in eGFR compared with baseline or new haemodialysis or death.
次要结局
- Development of Liver related decompensating events: worsening of ascites, acute Variceal bleed,SBP and non-SBP infections, hepatic encephalopathy,Hepatocellular carcinoma(1 year)
- Validation and comparision of new equation with known equations of GFR(1 year)
- Cumulative incidence of AKI and its impact on MAKE(1 year)
- AKD and CKD development(1 year)
- Need for Liver transplant or simultaneous liver kidney transplant(1 year)
- Numbers of hospitalisations(1 year)
研究者
研究点 (2)
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