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临床试验/NCT00462644
NCT00462644已完成不适用

A Single Dose of Etomidate During Rapid Sequence Induction in Trauma Patients Causes Significant Adrenocortical Insufficiency: A Prospective Randomized Study

University of Tennessee1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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)

研究者

申办方类型
Other

研究点 (1)

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