跳至主要内容
临床试验/EUCTR2013-002051-15-AT
EUCTR2013-002051-15-AT进行中(未招募)不适用

Systemic hypotension following intravenous administration of contrast medium during computed tomography.

Innsbruck Medical University, Department of Radiology, Section of Microinvasive Therapy0 个研究点开始时间: 2014年9月22日最近更新:
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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

  • Primary or secondary liver tumors treatable by SRFA.
  • Approval of an interdisciplinary cancer board for SRFA.
  • Adult patients > 18 years, American Society of Anesthesiologists (ASA) score I-III, scheduled for radiological interventions with CM (obligate application) under general anesthesia.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • Reduced mental status of the patient, history of psychiatric disorder, refusal by patient, failure to obtain written and informed consent.
  • Primary or secondary liver tumors larger than 12 cm in diameter or prediction of insufficient liver remnant, more than 7 lesions, lesions within 1 cm distance to the central bile duct, lesions infiltrating adjacent hollow viscera.
  • Liver cirrhosis classified higher than Child-Pugh class B, manifest ascites.
  • Estimated glomerular filtration rate (eGFR) <45.
  • Clotting disorders (PT < 50%, apTT >50 sec and thrombocytes < 50,000/mm3) or recent intake of platelet aggregation inhibitors
  • Evidence of intolerance or allergic reactions against both CM.
  • Contraindications to both CM according to Austrian Fachinformation
  • Antihypertensive treatment except Midazolam (Dormicum®, Roche Pharmaceutics, Vienna, Austria) orally 30 minutes prior to surgery at dose between 3.75 and 7.5 mg.

研究者

发起方
Innsbruck Medical University, Department of Radiology, Section of Microinvasive Therapy

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