Decompensation of Cirrhosis and Iron Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Iron is a crucial metal whose metabolism is tightly regulated. Iron deficiency or iron overload are both deleterious at the cellular, organic and systemic levels. In line with the major role of the liver in iron homeostasis, links between iron metabolism and acute on chronic liver failure have been highlighted. Nevertheless, due to the difficulty of accurately assessing iron metabolism in this situation, therapeutic intervention on iron metabolism in this setting is currently not codified.
A better understanding of these mechanisms is therefore essential, in particular by characterizing the impact of exposure to non-transferrin-bound iron in acute on chronic liver failure on short-term mortality.
Overall, a better understanding of the physiopathological mechanisms of iron should allow to optimize the martial balance in this condition and also improve therapeutic approaches.
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
- •Age ≥ 18 years old.
- •Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not.
- •Hospitalization for acute on chronic liver failure:
- •Ascites decompensation.
- •Or spontaneous infection of the ascites fluid (defined as PNN > 250/mm3 of ascites).
- •Or digestive hemorrhage related to portal hypertension (digestive fibroscopy showing active bleeding or stigmas of recent bleeding from esophageal and/or gastric varices).
- •Or hepatic encephalopathy (clinically defined +/- increase in ammonia and/or by electroencephalogram and classified in stages according to West-Haven).
- •Or hepato-renal syndrome (HRS-AKI criteria, EASL 2018).
- •Or bacterial infection (defined by a bacteremia identified by at least one blood culture and/or an infectious site authenticated on imaging).
- •Or Acute Alcoholic Hepatitis (histologically proven or not).
- •Non-opposition of the patient, relative or legal representative.
排除标准
- •Treatment with oral or intravenous iron in the month prior to hospitalization.
- •Implementation of a TIPS in the month prior to admission.
- •Presence of hepatocellular carcinoma with an expected survival < 3 months or any other progressive cancer.
- •Adult person subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.
结局指标
主要结局
Mortality
时间窗: day 28
次要结局
- Serum levels of abnormal iron(days 0, 2, 7 and 14)
- Ceruloplasmin ferroxidase activity(days 0, 2, 7 and 14)
- fungal infection(during hospitalization and a maximum of 28 days after admission)
- hepcidin blood levels(days 0, 2, 7 and 14)
- Ferritinemia(days 0, 2, 7 and 14)
- transferrinemia(days 0, 2, 7 and 14)
- transferrin saturation coefficient(days 0, 2, 7 and 14)
- Blood levels of manganese(days 0, 2, 7 and 14)
- Occurrence of complications(during hospitalization and a maximum of 28 days after admission)
- Bacterial infection(during hospitalization and a maximum of 28 days after admission)