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临床试验/EUCTR2006-000164-93-BE
EUCTR2006-000164-93-BE进行中(未招募)不适用

Effect of Nutritional Support on Liver Integrity during General Anesthesia for Laparoscopic Cholecystectomy.A Pilot Study - Nutritional support and liver

Department of Anesthesiology University Hospital Center0 个研究点开始时间: 2006年5月9日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • male and female patients between 18 and 75 year old, with Body Mass Index (BMI) < 30 kg/m2, able to read and understand French, with normal mental health, scheduled for elective laparoscopic cholecystectomy
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patients will be primarily excluded from the study if they suffer instability of vital functions, cancer, chronic endocrine diseases (diabetes mellitus, thyroid dysfunction, etc), neurological diseases, acute or chronic liver disturbances (control of Quick, bilirubin or transaminases), renal insufficiency (creatinine clearance < 50% of normal), congestive heart failure, glucocorticoid and/or catecholamine therapy, fever, gastrointestinal diseases and patients with alcohol or drug abuse; furthermore patients having received chemotherapy, hepatotoxic drugs, TPN in the preceding 15 days, or having undergone an operation in the preceding 30 days. Pregnant patients, inborn errors of amino acid metabolism as well as patients with history of severe drug hypersensitivity or allergic diathesis to egg proteins and soybean will be excluded as well. Bleeding during surgery with a transfusion need of more than 2 units of red blood transfusion and/or 4 units of fresh frozen plasma will lead to exclusion from the study. Serious adverse drug reactions, violation of the study protocol (e.g. infusion of less than 85% of the planned volume), the development of severe organ failure, or the need for surgical reintervention are defined as secondary exclusion criteria.

研究者

发起方
Department of Anesthesiology University Hospital Center

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