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临床试验/NCT04186572
NCT04186572Unknown不适用

Usefulness of the Variation of the CLIF-C ACLF Score in Patients With Acute on Chronic Liver Failure

Hospital El Cruce0 个研究点目标入组 30 人开始时间: 2019年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Evaluate the degree of severity of the ACLF with the CLIF-C ACLF score at the time of diagnosis and its variation on day 3 and 7

研究概览

简要总结

Patients with Acute on Chronic Liver Failure (ACLF) have high short-term mortality. The use of a severity score could define the patient's prognosis and would help determine in whom the treatment is effective or futile.

详细描述

Acute on Chronic Liver Failure (ACLF) is a syndrome characterized by the presence of an acute decompensation of cirrhosis, associated with failure of at least one other organ or extra hepatic system. It is characterized by high mortality in the short term and its prevalence varies between countries and regions.

It is an extraordinarily dynamic entity in which more than 50% of patients with less severe forms improve, while in those with 3 or more organ failures, the transplant rate is low and mortality is 90%. It is important to highlight that those patients with ACLF who manage to be transplanted have the same survival as cirrhotic patients without ACLF. There is no specific treatment, only life support and early determination of the precipitating factor and its eventual resolution.

Having tools that define the short-term prognosis of these patients, especially the variation of the score (CLIF-C ACLF) during the first week, would have an important clinical relevance, because it can help define the patients who benefit from the supportive treatment and in whom the therapeutic effort is futile.

The biomarker Neutrophil Gelatinase-Associated Lipocalin (NGAL) is increased in plasma and urine in patients with ACLF and could help improve the prognostic ability of the CLIF-C ACLF score.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Acute on Chronic Liver Failure

排除标准

  • Acute liver failure, terminal disease, pregnancy, previous liver transplant

结局指标

主要结局

Evaluate the degree of severity of the ACLF with the CLIF-C ACLF score at the time of diagnosis and its variation on day 3 and 7

时间窗: one week

The severity of the ACLF will be assessed by means of a score (CLIF_C ACLF) at the time of admission, day three and seven. Good evolution of the score will be considered when it decreases and bad evolution when it remains the same or increases.

次要结局

  • Correlate the variation of the score (CLIF-C ACLF) and mortality at 28, 60 and 90 days.(90 days)
  • Correlate the level of NGAL with the development of ACLF and its severity evaluated by the CLIF-C ACLF score.(1 day)
  • ACLF epidemiological evaluation.(90 days)

研究者

发起方
Hospital El Cruce
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nestor Pistillo

Head of Intensive Care Unit at Hospital El Cruce

Hospital El Cruce

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