A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Baseline Cortisol
研究概览
简要总结
Trauma patients are at increased risk for adrenal function insufficiency. A commonly used agent for rapid sequence intubation (RSI) is known to decrease adrenal function. We want to determine the incidence of adrenocortical insufficiency and its significance during the first 24 hours of resuscitation following RSI in trauma patients.
详细描述
The study will have two arms. Patients on one arm will be assigned to receive etomidate (0.3 mg/kg) and succinylcholine (1mg/kg) for RSI. Patients on the other arm will receive standard therapy at this institution which consists of Versed (generic name midazolam) (5 mg) plus fentanyl (100 mcgs) as well as succinylcholine for RSI. Both drug regimens have a rapid onset, short duration and short half-life.
Patients will be randomly assigned to one arm of the study. The trauma nurse emergency room responders, intensive care unit staff, or helicopter crew will pull a study envelope which will contain a randomization to either the etomidate arm or standard therapy arm. The numbers will correspond to a log, delineating which medication is given. The nurse will document the medication as RSI Study Drug - etomidate or RSI Study Drug - standard and the randomization packet number (ie, RSI Study Drug, etomidate, #1, RSI Study Drug, standard, #2, etc.) and will document the patient's name and medical record number on the study log in either the helicopter or the ER Resuscitation Bay.
Baseline cortisol level will be drawn prior to RSI. An additional cortisol level will be drawn 4-6 hours later. Following this level, a cortrosyn stimulation test will be performed by giving 0.25 mg cortrosyn IV and rechecking a cortisol level in 60 minutes. Adrenal insufficiency will be defined as a baseline cortisol level of <15 or an increase in cortisol of <9 after cortrosyn administration. Patients will be monitored for 24 hours for hemodynamics, IV fluid administration , and use of vasopressors. Patient will be resuscitated to adequate mean arterial blood pressure and urine output. Any patient found to be adrenal insufficient will be treated with hydrocortisone 50 mg IV every 6 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Trauma mechanism of injury
- •Patient requires rapid sequence induction for ventilatory support
排除标准
- •<18 years old
- •Prisoners
- •Pregnant women
- •Patients with a history of adrenal insufficiency
- •Patients with adrenal trauma documented by CT scan
- •Patients receiving corticosteroids in the previous year
研究组 & 干预措施
Etomidate
Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
干预措施: RSI sedation with etomidate/succinylcholine (Drug)
Fentanyl-Midazolam
Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
干预措施: RSI sedation with fentanyl/midazolam/succinylcholine (Drug)
结局指标
主要结局
Change in Baseline Cortisol
时间窗: 4-6hr after RSI
change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)
Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)
时间窗: 60 minutes after administration of cotrosyn
Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test
时间窗: pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test
Postintubation Cortisol (Baseline Cortisol Level)
时间窗: postintubation (baseline cortisol level)
cortisol level after randomization and rapid sequence induction
次要结局
- Hospital Length of Stay(time to hospital discharge in days)
- Intensive Care Unit (ICU) Length of Stay(time from hospital admission to transfer out of ICU to floor bed)
- Ventilator Days(time from intubation to extubation)
- Number of Deaths(death in hospital)
