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临床试验/EUCTR2009-009596-35-GB
EUCTR2009-009596-35-GB进行中(未招募)1 期

Optimisation of Peri-operative Cardiovascular Management to Improve Surgical Outcome (Optimise Trial) - Optimise

Queen Mary's, University of London0 个研究点目标入组 734 人开始时间: 2009年4月16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
734

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

入选标准

  • Adult patients undergoing major abdominal surgery involving the gastrointestinal tract that is expected to take longer than 90 minutes will be eligible for recruitment provided they satisfy one of the following criteria:
  • Age 65 years and over
  • Age 50-64 plus, one or more of:
  • -non-elective surgery;
  • -acute or chronic renal impairment (serum creatinine >130 µmol/l)
  • -diabetes mellitus
  • -presence of a risk factor for cardiac or respiratory disease
  • 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

  • Refusal of consent
  • Patients receiving palliative treatment only (likely to die within 30 days)
  • Acute myocardial ischaemia (within 30 days prior to randomisation)
  • Acute pulmonary oedema (within 7 days prior to randomisation)
  • Septic shock at time of enrolment
  • Thrombocytopenia (platelet count <50 x 109 l-1)
  • Patients who are receiving monoamine oxidase inhibitors (MAOIs)
  • Phaeochromocytoma
  • Severe Left ventricular outlet obstruction eg due to hypertrophic obstructive cardiomyopathy or severe aortic stenosis
  • Known hypersensitivity to dopexamine hydrochloride or disodium edentate
  • Pregnancy at time of enrolment
  • Failure to meet the inclusion criteria

研究者

发起方
Queen Mary's, University of London

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