Impact of Dexmedetomidine Infusion on the Time Course and Outcomes of Acute Respiratory Distress Syndrome (ARDS) in Patients Affected by the SARS-CoV-2 (COVID-19) Admitted to Critical Care Unit
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Mechanical ventilation
研究概览
简要总结
A continuous infusion of Dexmedetomidine (DEX) will be administered to 80 patients admitted to Critical Care because of signs of Respiratory Insufficiency requiring non-invasive ventilation. Measurements of respiratory performance and quantification of cellular and molecular inflammatory mediators. The primary outcome will be the avoidance of mechanical ventilation with secondary outcomes duration of mechanical ventilation, avoidance of delirium after sedation and association of mediators of inflammation to outcomes. Outcomes will be compared to a matched historical control (no DEX) series
详细描述
It will be an observational study, with no randomization. To evaluate the influence of Dexmedetomidine on the time course of ARDS in patients admitted to the ICU unit because of severe respiratory disease triggered by the SARS-CoV-2 (COVID-19) infection. Patients will be informed and asked to sign an Informed Consent Form.
Dexmedetomidine will be used as a sedative which is its admitted therapeutic indication in our country. Dosing will be according to its sedative properties as recommended by the manufacturer and regulation agencies. The only change is that we will study outcomes that have nothing to do with sedation but with a possible positive effect on the hyper-inflammatory state.
The study will be conducted in accordance with the "Orden SAS/3470/2009, of December 16, 2009. Government of Spain
Recruiting and Sample Size calculation We chose mortality as an endpoint to calculate sample size although our primary outcome is to minimize the requirements of mechanical ventilation. Mortality of patients admitted to the ICU because of SARS-CoV-2 (COVID-19) induced ARDS is 48%. Assuming a p value<0.05 and a power of 80%, to demonstrate a 10% decrease in mortality due to the effects of Dexmedetomidine 156 patients should be studied so there will two groups of 80 patients (cases vs historical controls).
However, due to the specific characteristics and the unknown duration of the pandemic, these numbers might not be definitive
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with respiratory insufficiency criteria candidates to non-invasive ventilation techniques (high flow oxygen masks, non-invasive mechanical ventilation)
- •SpO2 (at FiO2: 0.21) ≤ 93% equivalent to SaO2/FiO2≤442
- •PaO2/ FiO2 < 300
- •Bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph that must not be fully explained by cardiac failure or fluid overload, in the physician's best estimation using available information
排除标准
- •Affected by autoimmune disease
- •Under specific therapy with Monoclonal Antibodies targeting inflammatory mediators
研究组 & 干预措施
DEXMEDETOMIDINE
Patients receiving dexmedetomidine continuous infusion since their admittance to ICU. Continuous checking of the primary and secondary outcomes
干预措施: Dexmedetomidine Injectable Product (Drug)
结局指标
主要结局
Mechanical ventilation
时间窗: expected within first three days (non conclusive due to lack of evidence yet)
(Presence/Absence) requirement of mechanical ventilation
次要结局
- Duration of mechanical ventilation(expected within first seven days (non conclusive due to lack of evidence yet))
- Delirium on recovery from sedation(First 24 hours after retiring dexmedetomidine sedation)