Evaluation of Etomidate on Adrenal Function in Trauma Patients

NCT00462644 | Completed Results

• 1 other identifier: 05-050
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adrenal Insufficiency

Keywords

adrenal insufficiency; etomidate; rapid sequence induction

Outcome Measures

Primary Outcomes (4)

• Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test

  pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test

• Postintubation Cortisol (Baseline Cortisol Level)

  cortisol level after randomization and rapid sequence induction

  postintubation (baseline cortisol level)

• Change in Baseline Cortisol

  change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)

  4-6hr after RSI

• Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)

  60 minutes after administration of cotrosyn

Secondary Outcomes (4)

• 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

Study Arms (2)

Etomidate

ACTIVE COMPARATOR

Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications

Drug: RSI sedation with etomidate/succinylcholine

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.

Drug: RSI sedation with fentanyl/midazolam/succinylcholine

Interventions

RSI sedation with etomidate/succinylcholine DRUG

etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV

Etomidate

RSI sedation with fentanyl/midazolam/succinylcholine DRUG

100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV

Fentanyl-Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trauma mechanism of injury
• Patient requires rapid sequence induction for ventilatory support

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Related Publications (1)

• Hildreth AN, Mejia VA, Maxwell RA, Smith PW, Dart BW, Barker DE. Adrenal suppression following a single dose of etomidate for rapid sequence induction: a prospective randomized study. J Trauma. 2008 Sep;65(3):573-9. doi: 10.1097/TA.0b013e31818255e8.

  PMID: 18784570 RESULT

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Etomidate; Succinylcholine; Fentanyl

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Piperidines

Limitations and Caveats

Small trial most likely underpowered; large number of exclusions; other limitations discussed in published paper (PMID: 18784570).

Results Point of Contact

• Title: Amy N. Hildreth, MD
• Organization: Wake Forest University, Department of Surgery

ahildret@gmail.com

Study Officials

• Vicente A Mejia, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 19, 2007
• Study Start: February 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: September 1, 2006
• Last Updated: February 23, 2010
• Results First Posted: November 11, 2009

Record last verified: 2010-02

Locations

US (1)