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临床试验/EUCTR2015-000318-24-NL
EUCTR2015-000318-24-NL进行中(未招募)1 期

Stress Ulcer Prophylaxis in the Intensive Care Unit - SUP-IC

Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet0 个研究点目标入组 3,291 人开始时间: 2015年11月19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
3,291

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

  • Acute admission to the ICU AND
  • Aged = 18 years AND
  • One or more of the following risk factors:
  • 1.Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure < 90 mmHg, mean arterial blood pressure < 70 mmHg or lactate > 4 mmol/l)
  • 2.Acute or chronic intermittent or continuous renal replacement therapy
  • 3. Invasive mechanically ventilation which is expected to last > 24 hours. When in doubt of the forecast, the patient should be enrolled.
  • 4. Coagulopathy (platelets < 50 x 109/l or international normalized ratio (INR) > 1.5 or prothrombin time (PT) > 20 seconds) documented within the last 24 hours
  • 5. Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded)
  • 6.History of coagulopathy (platelets < 50 x 109/l or INR > 1.5 or PT > 20 seconds within 6 months prior to hospital admission
  • 7. History of chronic liver disease (portal hypertension, cirrhosis proven by biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding or hepatic encephalopathy in the past medical history)
  • 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 1500
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 1850

排除标准

  • Contraindications to PPI
  • Ongoing treatment with PPI and/or H2RA on a daily basis
  • GI bleeding of any origin during current hospital admission
  • Diagnosed with peptic ulcer during current hospital admission
  • Organ transplant during current hospital admission
  • Withdrawal from active therapy or brain death
  • Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma-hCG
  • Consent according to national regulations not obtainable

研究者

发起方
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet

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