Re-EValuating the Inhibition of Stress Erosions (REVISE) - COVID-19 Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Primary Safety Outcome: 90 Day Mortality
研究概览
简要总结
Commonly employed medications used in critically ill patients requiring life support include proton pump inhibitors (PPIs). These medications are thought to prevent gastrointestinal (GI) bleeding from stress-induced ulceration. Despite their widespread use, they do hold some risks which include infection in the form of pneumonia and diarrheal illnesses such as Clostridioides difficile infection (C. difficile). Emerging high-quality studies suggest PPI usage does not influence susceptibility to COVID-19 infection, however some studies suggest PPI use leads to poor outcomes in this population, including prolonged time on life-support and death. While we can appreciate the negative effects of PPI may be magnified in the sickest of patients, namely hospitalized patients with COVID-19, the beneficial or potentially harmful role they play in this population remains unclear.
We aim to build a clinical profile to further describe critically ill patients with COVID-19 in Ontario using the infrastructure of an ongoing multicenter clinical trial of acid suppression. We will identify characteristics that predict poor outcomes among sick COVID patients, examining the impact of PPIs on this population.
详细描述
The overall aims are to further characterize the high-risk population of COVID-19 patients nested within the multicenter REVISE trial. Specifically, we plan 1) to explore the impact of PPIs on mechanically ventilated critically ill COVID-19 patients, 2) describe the clinical course for patients with COVID-19 and identify characteristics that predict poor prognosis, and 3) compare outcomes to patients without COVID-19. The overall research questions are as follows:
- Do critically ill patients projected to receive mechanical ventilation for >48 hours with COVID-19 have different clinical outcomes without PPIs?
- Are there prognostically relevant demographic, biomarker and clinical data to characterize critically ill patients with COVID-19?
- Do critically ill patients with COVID-19 have significant higher rates of clinically important GI bleeding, 90-day mortality, and rates of infection when compared to a propensity-matched non-COVID REVISE cohort?
To accomplish this, the investigators propose to gather information in patients' medical charts including biomarkers drawn by the ICU team, venous thromboembolism (VTE) and tracheostomy timing, to link with extensive baseline characteristics and outcomes already collected in the REVISE trial (NCT03374800)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adults ≥18 years old projected to receive invasive mechanical ventilation for ≥48 hours according to the treating physician
排除标准
- •Already received invasive mechanical ventilation >72 hours during this hospital admission
- •Acid suppression for active gastrointestinal bleeding or high risk of bleeding (e.g., current bleeding, peptic ulcer bleeding within 8 weeks, recent severe esophagitis, Barrett's esophagus, Zollinger-Ellison syndrome); [dyspepsia or gastroesophageal reflux is not an exclusion criterion]
- •Acid suppression in the intensive care unit for >1 daily dose equivalent of a proton pump inhibitor or histamine-2-receptor antagonist
- •Dual antiplatelet therapy
- •Combined antiplatelet and therapeutic anticoagulation
- •Pantoprazole contraindication per local product information
- •Palliative care or anticipated withdrawal of advanced life support
- •Previous enrolment in REVISE, or a related trial, or trial for which co-enrolment is prohibited
- •Patient, proxy or physician declines
结局指标
主要结局
Primary Safety Outcome: 90 Day Mortality
时间窗: 90 days after randomization
Mortality status at day 90 post randomization
Rate of clinically important gastro-intestinal bleeding
时间窗: 90 days
The primary efficacy outcome is clinically important GI bleeding occurring in the ICU or resulting in ICU readmission during the index hospital stay. The definition of clinically important GI bleeding is overt GI bleeding (i.e., hematemesis, frank blood or coffee ground nasogastric aspirate, melena or hematochezia) plus 1 of the following in the absence of other causes: 1. Hemodynamic change defined as a spontaneous decrease in invasively monitored mean arterial pressure or non-invasive systolic or diastolic blood pressure of \>20 mmHg, or an orthostatic increase in pulse rate of \>20 beats/minute and a decrease in systolic blood pressure of \>10 mmHg, with or without vasopressor initiation or increase; 2. vasopressor initiation; 3. hemoglobin decrease of \>2 g/dl (20 g/L) within 24 h of bleeding; 4. transfusion of \>2 units red blood cells within 24 h of bleeding; or 5. therapeutic intervention (e.g., therapeutic endoscopy, angiography, surgery).
次要结局
- Renal replacement therapy(While in ICU,censored at 90 days after randomization)
- Patient important GI bleeding(Censored at 90 days after randomization)
- C. difficile infection(90 days (during the index hospital admission, censored at 90 days))
- Hospital mortality(While in hospital, censored at 90 days after randomization)
- Ventilator-associated pneumonia(90 Days (while in ICU,censored at 90 days after randomization))