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

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ClinicalTrials.gov Identifier: NCT00615862
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date February 1, 2008
First Posted Date February 14, 2008
Last Update Posted Date February 22, 2012
Study Start Date March 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 13, 2008)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship Between Alcohol Use Disorders and Cortisol Levels in Patients With Sepsis
Official Title Relationship Between Alcohol Use Disorders and Cortisol Levels in Patients With Sepsis
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
  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.
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.
Condition
  • Sepsis
  • Alcoholism
Intervention 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.
Study Groups/Cohorts 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-.
Intervention: Other: Observational study; no interventions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February 13, 2008)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00615862
Other Study ID Numbers HM11399
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor Virginia Commonwealth University
Collaborators Not Provided
Investigators
Principal Investigator: Marjolein de Wit, MD, MS Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date June 2009