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 3,350 人开始时间: 2015年3月11日最近更新: 2018年1月29日

试验速览

暂无简介。

•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

•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

发起方

Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet