EUCTR2013-004644-28-DE进行中（未招募）1 期
Administration of Rifaximin to improve Liver Regeneration and Outcome following Major Liver Resection - ARROW
RWTH Aachen University, represented by the Rector, himself, represented by the Dean of the Medical Faculty0 个研究点目标入组 96 人开始时间: 2014年3月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
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
- •1.Patients undergoing a liver resection of at least 3 segments
- •2.Age = 18 years = 80 years
- •3.BMI 18 – 40
- •4.Patients with ASA I-III
- •5.Written informed consent prior to study participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Patients assessed ASA IV-V
- •2.Contraindication for MRT or LiMAx
- •3.Need for extrahepatic procedures additive to partial liver resection
- •4.Participation in other liver related trials
- •5.BMI <18, > 40
- •6.Previous liver transplantation or porto-systemic shunt
- •7.Concomitant acute infectious diseases
- •8.Dialysis dependent renal failure
- •9.Hypersensitivity to Rifaximin
- •10.Concomitant Heated Intraperitoneal Chemotherapy (HIPEC) treatment
- •11.ALPPS (associating liver partition and portal vein ligation for staged hepatectomy)
- •12.Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
- •13.Lactating females
- •14.The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
- •15.The subject received an investigational drug within 30 days prior to inclusion into this study
- •16.The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
- •17.The subject is unwilling or unable to follow the procedures outlined in the protocol
- •18.The subject is mentally or legally incapacitated
研究者
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