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
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