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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00615862
First received: February 1, 2008
Last updated: February 21, 2012
Last verified: June 2009
  Purpose

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.


Condition Intervention
Sepsis
Alcoholism
Other: Observational study; no interventions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Alcohol Use Disorders and Cortisol Levels in Patients With Sepsis

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
  1. Diagnosis of alcohol use disorders will be made through the use of a validated questionnaire.
  2. Blood collected as part of routine patient care (and that is destined to be discarded) will be evaluated for a number of immune markers. Cortisol levels measured as part of routine care will be recorded.
  3. Delirium will be assessed through the use of a validated instrument.

Estimated Enrollment: 40
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615862

Locations
United States, Virginia
Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Marjolein de Wit, MD, MS Virginia Commonwealth University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00615862     History of Changes
Other Study ID Numbers: HM11399
Study First Received: February 1, 2008
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Sepsis, alcoholism, cortisol, delirium, critical care

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Sepsis
Toxemia
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on July 28, 2014