Gastrointestinal Bleeding in Critically Ill Patients: Prevalence, Risk Factors, and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 310
- 主要终点
- Incidence of clinically important ICU-acquired gastrointestinal bleeding
研究概览
简要总结
This prospective cohort study aims to determine the prevalence of gastrointestinal bleeding among critically ill patients admitted to intensive care units, identify independent risk factors, and describe clinical outcomes including ICU length of stay, transfusion requirements, and mortality at Assiut University Hospitals.
详细描述
Gastrointestinal bleeding is a serious complication in critically ill patients and is associated with increased morbidity and mortality. This prospective observational cohort study will include adult patients (≥18 years) admitted to the intensive care units of Assiut University Hospitals.
Patients will be followed during their ICU stay for the occurrence of clinically important gastrointestinal bleeding (overt or occult) occurring ≥24 hours after admission. Clinical, laboratory, and treatment-related data will be collected to identify independent risk factors and to assess associated clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age 18 years or older
- •Admission to the intensive care unit
- •Onset of gastrointestinal bleeding after ≥24 hours of ICU admission (to distinguish ICU-acquired bleeding)
- •Overt gastrointestinal bleeding (hematemesis, melena, hematochezia, or bloody nasogastric aspirate) and/or occult bleeding confirmed by fecal occult blood test or endoscopy
- •Written informed consent (from patient or legal representative)
排除标准
- •- Age less than 18 years
- •Pregnancy
- •Gastrointestinal bleeding clearly due to trauma or recent gastrointestinal surgery/procedure
- •Known bleeding disorder unrelated to critical illness
- •Recent receipt of peptic ulcer prophylaxis (two or more doses)
- •Incomplete medical records or loss to follow-up
- •Refusal to participate
研究组 & 干预措施
Single cohort: Critically ill adult patients admitted to ICU
Adult patients admitted to the intensive care units who will be followed for the occurrence of ICU-acquired gastrointestinal bleeding and its associated risk factors and outcomes.
结局指标
主要结局
Incidence of clinically important ICU-acquired gastrointestinal bleeding
时间窗: Up to 30 days
Proportion of critically ill patients who develop clinically important gastrointestinal bleeding (overt bleeding with hemodynamic compromise or significant hemoglobin drop, or occult bleeding confirmed by fecal occult blood test or endoscopy) occurring 24 hours or more after ICU admission.
次要结局
- Independent risk factors for gastrointestinal bleeding(Up to 30 days)
- ICU length of stay(Up to 30 days)
- Blood transfusion requirement(Up to 30 days)
- ICU mortality(Up to 30 days)
- Need for endoscopic or surgical intervention(Up to 30 days)
研究者
Haidy Mohamed Mahmoud
Resident Physician
Assiut University