N-Acetyl-cysteine in Early Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Ventilator days
研究概览
简要总结
We would study whether there is any measurable benefit of the administration of nebulized n-acetyl-cysteine to acute respiratory distress syndrome patients starting within 48 hours of intubation and mechanical ventilation.
详细描述
Objectives / Research Aims The overall objectives of this study are to demonstrate whether a protocol for the early use of inhaled N-acetylcysteine improves mortality, ventilator days, ICU days, hospital stay, as well as the need for other "rescue" modalities, such as use of advanced ventilator modalities (such as airway pressure release ventilation [APRV]), paralytics, and prone positioning. As this is a pilot study, we would address the feasibility of recruiting and consenting patients as well as to ascertain the sample size that would be needed to power the desired endpoints in a larger study.
Setting The project will be performed in the Medical Intensive Care Unit at Palmetto Health Richland using subjects with severe acute respiratory distress syndrome that are identified within 48 hours of their disease process.
Resources Available It is not uncommon for the patients admitted with or that develop acute respiratory distress syndrome to receive breathing treatments of some variety, such as bronchodilators. This study would take an existing practice and add a relatively inexpensive medication, N-acetylcysteine.
It will be straightforward and require relatively little time to calculate the metrics for the patients enrolled in this study as these data are typically collected for intensive care unit patients already.
Our respiratory therapists are already very experienced and proficient at the administration of inhaled N-acetylcysteine. Likewise, the academic intensive care team would be able to readily classify the patients that are appropriate for this study as the partial pressure of oxygen to fraction of inspired oxygen (P/F) ratio is typically documented for every ventilated patient admitted to our unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Inclusion criteria includes adult patients admitted to the medical intensive care unit or coronary care unit, being mechanically ventilated with a positive end expiratory pressure greater than 5 cm H2O, with noncardiogenic pulmonary edema on chest x-ray within 48 hours of being noted to have a P/F ratio < 150.
排除标准
- •Exclusion criteria includes patients < 18 years of age, patients for whom no aggressive measures are desired, patients who are already receiving "rescue methods" (prone positioning, advanced ventilator modes, paralytics), trauma patients, vulnerable patient groups (pregnant, prisoners), patients who have undergone a surgical operation during their time on the ventilator, patients with end stage liver disease, patients on chronic ventilators, and asthmatics.
研究组 & 干预措施
NAC and albuterol
The procedure involved would be the administration of N-acetylcysteine via nebulization, which would be administered to the patient by respiratory therapy in the dosage of 2 mL 20% solution acetylcysteine (or 4 mL of 10% solution) along with inhaled albuterol via endotracheal tube every six hours for 72 hours total. The control arm will have saline administered with the albuterol every six hours. Both arms will have additional bronchodilators administered as indicated clinically (bronchospasm, COPD, peak airway pressure elevation, etc.).
干预措施: N-acetyl cysteine (Drug)
结局指标
主要结局
Ventilator days
时间窗: From time of intubation until one of predefined endpoints (up to 60 days)
Number of days requiring mechanical ventilation
次要结局
- Mortality(up to 60 days)
- ICU days(From time of admission to the ICU until transfer out of the unit (up to 60 days))
- P/F ratio(Daily until the predefined endpoints (up to 60 days))
- Use of "rescue" maneuvers(Daily until the predefined endpoints (up to 60 days))