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临床试验/EUCTR2008-003731-20-SE
EUCTR2008-003731-20-SE进行中(未招募)不适用

Postoperative Hyperbaric Oxygen treatments to reduce complications in Diabetic patients undergoing Vascular Surgery (HODIVA) - A double blind, randomized controlled study - HODIVA

Karolinska Universitetssjukhuset0 个研究点开始时间: 2008年8月6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)

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

  • Patients are eligible for inclusion if the following criteria are fulfilled
  • 1.Informed consent obtained
  • 2.Scheduled for lower extremity open vascular surgery
  • 3.Diabetes treated with insulin or oral antidiabetic medicine
  • 4. 18 years or older
  • 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 having any of the following at randomization will not be included in the study
  • 1.Contraindications to HBO therapy
  • 2.Pregnancy
  • 3.Patients already in HBO treatment
  • 4.Creatinine > 250 mmol/L
  • 5.NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber
  • 6.Malignancy or other serious medical condition where it is likely that the patient will significantly deteriorate or not survive within the two years of follow up.
  • 7.Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices.
  • 8.Mental condition making the subject unable to understand the concepts and risk of the study

研究者

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