Official Title: “Relationship Between Alcohol Use Disorders and Cortisol Levels in Patients With Sepsis”

Patients with alcohol use disorders are often cared for in the intensive care unit (ICU). We estimate that close to half of the patients we care for in our ICU have alcohol use disorders. One of the reasons that patients with alcohol use disorders are frequently cared for in our ICU is because patients with alcohol use disorders are at higher risk of developing infections. The medical term for infections is sepsis. When an infection develops, patients with alcohol use disorders tend to get more severely ill compared to patients who do not have alcohol use disorders. Patients with alcohol use disorders are also at higher risk of dying when they develop severe infections.

The purpose of this study is to determine why patients with alcohol use disorders become more severely ill when they develop infections. There are a number of reasons why this is possible. One reason is that a hormone called cortisol is higher in individuals with alcohol use disorders (who do not have infections). This hormone is also higher in patients who are at increased risk of dying from severe infections. One of the aims of this study is to see if cortisol levels are higher in patients with alcohol use disorders compared to those who do not have alcohol use disorders.

Another reason why patients with alcohol use disorders are at increased risk of developing infections is because their immune system is not functioning properly. A second aim of this study is to see if certain markers of immune function are different in patients with alcohol use disorders compared to patients without alcohol use disorders.

Patients with alcohol use disorders are also more likely to become confused when they are in the ICU. This condition is called delirium. Delirium is marked by abrupt onset of altered level of consciousness, disorganized thinking, and inattention that changes over time.

Delirium tremens is one form of delirium. About 80% of our ICU patients develop delirium, and many patients who do not have alcohol use disorders develop the disorder as well.

Patients with alcohol use disorders who have high cortisol levels have a higher chance of developing delirium compared to patients with normal cortisol levels. A third aim of this study is to examine the relationship between delirium and cortisol in both patients with and without alcohol use disorders.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Other: Observational study; no interventions
  • Validated questionnaires will be administered. Blood samples will be analyzed for levels of immune markers as well as cortisol. This is an observational study and patients will not undergo any treatment as part of study participation. Patients will not receive medications or other interventions if they participate in the study. Blood samples analyzed are from samples remaining in the hospital laboratory that were collected as part of routine patient care and destined to be discarded.

Arms, Groups and Cohorts in this Clinical Trial

• : AUD+ and AUD-
  • AUD stands for alcohol use disorders. Patients with alcohol use disorders are assigned the label AUD+. Patients without alcohol use disorders are assigned the label AUD-.

Primary Measures

• The primary outcome of this study evaluating patients with sepsis is to ascertain differences in cortisol levels between patients with alcohol use disorders and those without alcohol use disorders.
  • Time Frame: Within 24 hours of hospital admission
    Safety Issue?: No

Secondary Measures

• A secondary outcome in this study evaluating patients with sepsis is to determine differences in immune function between patients with alcohol use disorders and those without alcohol use disorders.
  • Time Frame: Within 24 hours of hospital admission
    Safety Issue?: No
• Another secondary aim of this study evaluating patients with sepsis is to determined if higher cortisol levels are associated with increased risk of developing delirium.
  • Time Frame: Within 72 hours of hospital admission
    Safety Issue?: No

Inclusion Criteria:

• Patients admitted to the medical intensive care unit at Virginia Commonwealth
• University Medical Center (also known as Medical College of Virginia Hospitals) in Richmond, Virginia

Exclusion Criteria:

Study exclusion criteria are:

• Age < 18 years old
• Prisoners under legal coercion or restriction
• Pregnant women
• Admission diagnosis other than sepsis
• Admitted to the medical intensive care unit service from location other an emergency department
• No cortisol level measured by the pathology laboratory at Virginia Commonwealth
• University Medical Center within the first 24 hours after presentation to an emergency department; AND
• Administration of etomidate within 24 hours prior to measurement of cortisol levels.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Virginia Commonwealth University

Overall Clinical Trial Officials and Contacts

Marjolein de Wit, MD, MS Principal Investigator Virginia Commonwealth University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00615862

Study ID Number: HM11399

ClinicalTrials.gov Identifier: NCT00615862

Health Authority: United States: Institutional Review Board