The Million Anesthesia Cases Study (MACS) - Retrospective and Prospective Characterization of Perioperative Fasting Practices and Their Effects on Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200,000
- 试验地点
- 1
- 主要终点
- Postoperative nausea and vomiting (PONV)
研究概览
简要总结
Perioperative fasting has historically been viewed as a low-risk intervention. However, preliminary data indicate that perioperative loss of nutrition and fluids is likely harmful. This study intends to characterize perioperative fasting practices and their potential effects on clinical outcomes through possible effects on patient well-being (anxiety, hunger, thirst), physiology (hypovolemia, hypotension), perioperative aspiration, etc. The research team hypothesized that in addition to known adverse effects on patients' well-being, prolonged preoperative fasting adversely affects circulating blood volume-related (hypotension, decreased urine output etc.) and glucose metabolism-related (e.g., hypo/hyperglycemia) perioperative physiology. The investigators will also test for an association between the duration of preoperative fasting and the risk of perioperative pulmonary aspiration.
Additional knowledge on the potential adverse effects of preoperative fasting will inform preoperative fasting policies and research interventions that are relevant to hundreds of millions of patients subjected to preoperative/preprocedural fasting worldwide each year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic or therapeutic procedure with anesthesia care (general anesthesia, regional anesthesia, sedation, or a combination of the above)
排除标准
- •Not receiving anesthesia care
- •Lack of medical record data in Epic electronic medical record system
研究组 & 干预措施
Patients who receive anesthesia care
干预措施: Preoperative fasting (Other)
结局指标
主要结局
Postoperative nausea and vomiting (PONV)
时间窗: 12 hours postoperatively
The co-primary outcome of PONV is defined as administration ≥ 1 antiemetic drug within 12 h postoperatively.
Intraoperative hypotension
时间窗: Intraoperative period.
The co-primary outcome of intraoperative hypotension is defined as an area under the curve of intraoperative mean arterial pressure \<65 mm Hg.
Perioperative acute kidney injury (AKI)
时间窗: Postoperative days 0 to 7
The co-primary outcome of perioperative AKI is defined as stage 1 or higher, based on Kidney Disease Improving Global Outcomes criteria (creatinine rise ≥ 0.3 mg/dl within 48 h or ≥ 1.5 times baseline) from postoperative day (POD) 0 until POD 7
次要结局
- Incidence of prolonged preoperative fasting for clear liquids(48 hours preoperatively)
- Severity of prolonged clear liquid fasting(48 hours preoperatively)
- Perioperative hypoglycemia(12 hours preoperatively to 24 hours postoperatively)
- Perioperative hyperglycemia(12 hours preoperatively to 24 hours postoperatively)
- Perioperative AKI stage 2 or higher.(Postoperative days 0 to 7)
- Myocardial injury after noncardiac surgery (MINS)(Postoperative day 0 to 3)
研究者
Alexander Nagrebetsky, MD MSc
Physician-Investigator
Massachusetts General Hospital