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临床试验/CTRI/2022/09/045814
CTRI/2022/09/045814招募中3 期

Pantoprazole stress ulcer prophylaxis in preventing endoscopically confirmed stress related mucosal damage in critically ill mechanically ventilated medical ICU patients receiving enteral nutrition. A prospective randomized placebo-controlled trial.

IMS and SUM hospital0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • All adult (18 years or older) patients who, will be getting ad-mitted to the critical care medicine ICU and mechanically ven-tilated and receiving enteral nutrition with one or more of the following risk factors for gastrointestinal bleeding:
  • Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure below 90 mmHg, mean arterial blood pressure below 70 mmHg or plasma lactate level 4 mmol/l or above).
  • Acute or chronic intermittent or continuous renal replace-ment therapy (RRT).
  • Invasive mechanical ventilation which is expected to last for more than 24 hours.
  • Coagulopathy (platelets below 50 × 109/l, or international normalized ratio (INR) above 1.5, or prothrombin time (PT) above 20 s [ documented within the last 24 hours].
  • Ongoing treatment with anticoagulant drugs (prophylactic doses excluded).
  • History of coagulopathy (platelets below 50 × 109/l or INR above 1.5 or PT above 20 s (within the 6 months prior to hospital admission).
  • History of chronic liver disease (portal hypertension, cirrho-sis proven by biopsy, computed tomography (CT) scan or ul-trasound or history of variceal bleeding or hepatic encepha-lopathy)

排除标准

  • Contraindications to proton pump inhibitors: any history of intolerance to proton pump inhibitor or, treatment with anti HIV medication.
  • Ongoing treatment with proton pump inhibitors and/or histamine-2-receptor antagonists on a daily basis. Ongoing is defined as treatment not being discontinued at ICU admission Gastrointestinal bleeding of any origin (both upper and lower gastro-intestinal bleeding) during current hospi-tal admission, documented in the patient charts).
  • Diagnosed with peptic ulcer confirmed by en-doscopy or other method during current hospital admission.
  • Patient presenting with GI bleed or currently on-going GI bleed.
  • Organ transplant during current hospital admis-sion.
  • Withdrawal from active therapy or brain death documented in the patient charts.
  • Pregnancy.
  • Not giving consent.
  • Patients not mechanically ventilated
  • Patients not receiving enteral nutrition

研究者

发起方
IMS and SUM hospital

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