Diagnosis and Pathogenetic Mechanisms in Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Determine the prevalence of cirrhotic cardiomyopathy in critically ill patients with cirrhosis
研究概览
简要总结
Cirrhotic cardiomyopathy is associated with increased risk of complications like hepatorenal syndrome, refractory ascites, impaired response to stressors including sepsis, bleeding or transplantation, poor health related quality of life and increased morbidity and mortality. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre.
详细描述
The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality.
In this project the investigators will screen critically ill patients with cirrhosis admitted to the intensive care unit for presence of cirrhotic cardiomyopathy and perform point-of-care echocardiography, electrocardiography, and cardiorenal biomarker tests for determination of outcomes in CCM. In patients who do not survive, the cardiac histology will be assessed by ultrasound guided myocardial biopsy to assess degree of inflammation and fibrosis in CCM.
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 with cirrhosis who have been diagnosed by clinical, biochemical, histological (when available) criteria plus ultrasound imaging will be included if they meet the following:
- •Age range of 18-65 years
- •Cirrhosis with critical illness admitted to the Liver Intensive Care Unit
排除标准
- •Age >65 years
- •Chronic renal disease
- •Pregnancy and peripartum cardiomyopathy
- •Valvular heart disease
- •Sick sinus syndrome/ Pacemaker
- •Transjugular intrahepatic porto systemic shunt (TIPS) insertion
- •Hepatocellular carcinoma
- •Anemia Hb < 8gm/dl in females, and < 9 gm/dl in males at the time of assessment
结局指标
主要结局
Determine the prevalence of cirrhotic cardiomyopathy in critically ill patients with cirrhosis
时间窗: At Enrollment
CCM is independent of etiology, and all patients should be assessed for this under diagnosed complication of liver disease. The presence of metabolic syndrome, use of alcohol and cirrhosis can contribute synergistically as risk factors for clinically undiagnosed case of CCM. In a nutshell, the cirrhotic heart displays a variation of structure and size, atherosclerotic lesions, and myocardium hypertrophy with impaired functioning, with fibrosis and remodeling in late stages. The prevalence of patients with CCM diagnosed as per the 2020 CCM criteria of the AASLD will be assessed.
次要结局
- Determine the POCUS determinants of cardiac dysfunction in critically ill patients with cirrhosis(At Enrollment)
- Determine the cardiac histology changes in critically ill patients with cirrhosis(At the time of demise)
- Determine severity of cardiac dysfunction in critically ill patients with cirrhosis(At Enrollment)
研究者
Madhumita Premkumar
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh