Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of patients with Complete Response in HRS-AKI
研究概览
简要总结
Point-of-care echocardiography (POC-Echo) is used to determine left ventricular systolic and diastolic dysfunction (LVDD), inferior vena cava (IVC) dynamics and volume status in cirrhosis and Acute-on-chronic liver failure ACLF accurately.
We will assess IVC dynamics, LV systolic function [LV ejection fraction (EF) & cardiac output (CO)], and diastolic dysfunction (E/e', e' and E/A ratio) and urinary biomarkers (cystatin C and NGAL) in patients with cirrhosis and ACLF with hepatorenal syndrome-acute kidney injury (HRS-AKI).
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
- •Cirrhosis of any Etiology
- •Patient with acute kidney injury meeting HRS-AKI criteria
排除标准
- •Hepatocellular carcinoma
- •Patients with active variceal bleeding
- •HIV or severe immunocompromised state
- •Chronic kidney disease (CKD) on renal replacement therapy (RRT),
- •Previous transjugular intra hepatic portosystemic shunt (TIPS)
- •Porto-pulmonary hypertension,
- •Coronary artery disease
- •Congenital or valvular heart disease
- •Prosthetic cardiac valves
结局指标
主要结局
Number of patients with Complete Response in HRS-AKI
时间窗: Day 7
Complete response is defined as a reversal in AKI with a final serum Creatinine (sCr) value of ≤ 0.3 mg/dL of the baseline.
Cardiac output measurement by echocardiography
时间窗: Day 0, Day 2, Day 7.
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0 and 48 hours after enrollment. The cardiac output at 7 days after enrollment will also be documented. he Doppler velocity time integral (VTI) method in estimating stroke volume and cardiac output correlates well with results of concurrent thermodilution cardiac output determinations in patients without significant left-sided valvular regurgitation. Cardiac output(CO), Stroke volume (SV), Heart rate (HR) CO = \[SV \* HR\]/ 1000
Number of patients with Non-Response in HRS-AKI
时间窗: Day 7
Non-responder is defined if the sCr did not decrease or increased from the baseline.
IVC size and collapsibility changes
时间窗: Day 7.
IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.
Number of patients with Partial Response in HRS-AKI
时间窗: Day 7
Partial response is defined as regression in the stage of AKI with a final sCr \> 0.3 mg/dL above the baseline.
次要结局
- Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level(Day 0 and Day 7)
- Change in Galectin-3 level(Day 0 and Day 7)
- Change in NT Pro brain natriuretic peptide (BNP) level(Day 0 and Day 7)
- Change in plasma renin activity level(Day 0 and Day 7)
研究者
Madhumita Premkumar
Associate Professor, Department of Hepatology
Post Graduate Institute of Medical Education and Research, Chandigarh