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临床试验/NCT01700231
NCT01700231已完成不适用

Monitoring Plasma and Hemodynamic Markers in Patients Undergoing Liver Resection to Identify Pathophysiological Mechanisms and Predict Clinical Outcome

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Perioperative blood parameters and HVPG

研究概览

简要总结

Introduction Liver resection is considered the only curative treatment option for mCRC patients without extrahepatic disease and is accepted practice. Despite substantial improvements in surgical techniques, postoperative morbidity and mortality remain an important concern after major resections. Complications of liver resection, although rare, include liver failure and acute kidney injury as indicated by oliguria and increased serum creatinine. The underlying pathophysiological pathways of post-operative renal alteration following liver resection is an increase in portal venous pressure, based on observations in animal models or small cohorts. The corpus of data is derived from patients with liver cirrhosis and subsequent hepatorenal syndrome. These data are limited since cirrhosis cannot distinguish between metabolic changes, portal hypertension and impaired liver function in the elucidation of the pathogenesis of renal alterations. Liver resection is therefore a potent model to evaluate the impact of portal hypertension on the kidney despite stable liver function.

The most significant factor determining morbidity and mortality following hepatectomy is the ability of the remnant liver to regenerate. In this context, several growth factors were shown to regulate the highly orchestrated process of liver regeneration (LR).

Hypothesis The investigators will therefore test the hypothesis that liver resection leads to a sustained increase of portalvenous pressure with a subsequent episode of oliguric renal impairment, correlating with the quantity of resected liver.

Furthermore, the investigators will examine the relationship between postoperative liver regeneration and circulating growth factor levels in patients undergoing hepatectomy. Based on the preclinical data the investigators hypothesize that a circulating growth factor levels will be associated with delayed liver regeneration, an increased incidence of postoperative liver dysfunction and concomitant worse clinical outcome.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with neoplastic liver tumors undergoing elective hepatectomy.

排除标准

  • Non elective hepatic surgery, preoperative HVPG > 10 mmHG, preoperative renal failure

结局指标

主要结局

Perioperative blood parameters and HVPG

时间窗: 90 postoperative days

Time course and predictive potential of blood parameter and HVPG in patients undergoing liver resection. Clinical outcome parameters are postoperative morbidity, mortality and liver dysfunction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edith Fleischmann

Clinical Professor

Medical University of Vienna

研究点 (1)

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