Relationship Between Alcohol Use Disorders and Cortisol Levels in Patients With Sepsis

February 21, 2012 updated by: Virginia Commonwealth University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients admitted to the medical intensive care unit at Virginia Commonwealth University Medical Center (also known as Medical College of Virginia Hospitals) will be eligible for study participation unless they meet study exclusion criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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-.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 24 hours of hospital admission

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Within 24 hours of hospital admission
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
Within 72 hours of hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM11399

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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