SepsisNCT00615862
Relationship Between Alcohol Use Disorders and Cortisol Levels in Patients With Sepsis
An observational study of Sepsis and Alcoholism, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Alcoholism
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)
Richmond, Virginia, 23298
About this study
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.
Read more
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.
- Conditions
- Sepsis, Alcoholism
- Being tested
- Observational study; no interventions
- Keywords
- Sepsis, alcoholism, cortisol, delirium, critical care
- Medical subject headings
- Sepsis, Alcoholism, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study; no interventionsOther
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 group | Role | What they receive |
|---|---|---|
| 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-. Receives: Other: Observational study; no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours of hospital admission
Secondary outcomes (2)
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.
Measured: 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.
Measured: Within 72 hours of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolein de Wit, MD, MS, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615862
- Sponsor's protocol ID
- HM11399
- Status last verified
- Jun 2009
- First submitted
- 1 Feb 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Brien JM Jr, Lu B, Ali NA, Martin GS, Aberegg SK, Marsh CB, Lemeshow S, Douglas IS. Alcohol dependence is independently associated with sepsis, septic shock, and hospital mortality among adult intensive care unit patients. Crit Care Med. 2007 Feb;35(2):345-50. doi: 10.1097/01.CCM.0000254340.91644.B2.
PubMed 17205003Moss M, Parsons PE, Steinberg KP, Hudson LD, Guidot DM, Burnham EL, Eaton S, Cotsonis GA. Chronic alcohol abuse is associated with an increased incidence of acute respiratory distress syndrome and severity of multiple organ dysfunction in patients with septic shock. Crit Care Med. 2003 Mar;31(3):869-77. doi: 10.1097/01.CCM.0000055389.64497.11.
PubMed 12626999de Wit M, Best AM, Gennings C, Burnham EL, Moss M. Alcohol use disorders increase the risk for mechanical ventilation in medical patients. Alcohol Clin Exp Res. 2007 Jul;31(7):1224-30. doi: 10.1111/j.1530-0277.2007.00421.x. Epub 2007 May 20.
PubMed 17511746de Wit M, Wan SY, Gill S, Jenvey WI, Best AM, Tomlinson J, Weaver MF. Prevalence and impact of alcohol and other drug use disorders on sedation and mechanical ventilation: a retrospective study. BMC Anesthesiol. 2007 Mar 14;7:3. doi: 10.1186/1471-2253-7-3.
PubMed 17359534Lipiner-Friedman D, Sprung CL, Laterre PF, Weiss Y, Goodman SV, Vogeser M, Briegel J, Keh D, Singer M, Moreno R, Bellissant E, Annane D; Corticus Study Group. Adrenal function in sepsis: the retrospective Corticus cohort study. Crit Care Med. 2007 Apr;35(4):1012-8. doi: 10.1097/01.CCM.0000259465.92018.6E.
PubMed 17334243Gianoulakis C, Dai X, Brown T. Effect of chronic alcohol consumption on the activity of the hypothalamic-pituitary-adrenal axis and pituitary beta-endorphin as a function of alcohol intake, age, and gender. Alcohol Clin Exp Res. 2003 Mar;27(3):410-23. doi: 10.1097/01.ALC.0000056614.96137.B8.
PubMed 12658106Kudoh A, Katagai H, Takase H, Takazawa T. Increased cortisol response to surgery in patients with alcohol problems who developed postoperative confusion. Alcohol Clin Exp Res. 2004 Aug;28(8):1187-93. doi: 10.1097/01.alc.0000134229.19493.fc.
PubMed 15318117de Wit M, Wiaterek GK, Gray ND, Goulet KE, Best AM, Clore JN, Sweeney LB. Relationship between alcohol use disorders, cortisol concentrations, and cytokine levels in patients with sepsis. Crit Care. 2010;14(6):R230. doi: 10.1186/cc9385. Epub 2010 Dec 22.
PubMed 21176217
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Alcohol Use Disorders and Cortisol Levels in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT00615862
- Acronym / sponsor ID
- HM11399
- Conditions
- Sepsis, Alcoholism
- Keywords
- Sepsis, alcoholism, cortisol, delirium, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUD+ and AUD- | – | Other: Observational study; no interventionsAUD 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-. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study; no interventionsValidated 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. | Other | AUD+ and AUD- |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Background: PubMed 17205003O'Brien JM Jr, Lu B, Ali NA, Martin GS, Aberegg SK, Marsh CB, Lemeshow S, Douglas IS. Alcohol dependence is independently associated with sepsis, septic shock, and hospital mortality among adult intensive care unit patients. Crit Care Med. 2007 Feb;35(2):345-50. doi: 10.1097/01.CCM.0000254340.91644.B2.
- Background: PubMed 12626999Moss M, Parsons PE, Steinberg KP, Hudson LD, Guidot DM, Burnham EL, Eaton S, Cotsonis GA. Chronic alcohol abuse is associated with an increased incidence of acute respiratory distress syndrome and severity of multiple organ dysfunction in patients with septic shock. Crit Care Med. 2003 Mar;31(3):869-77. doi: 10.1097/01.CCM.0000055389.64497.11.
- Background: PubMed 17511746de Wit M, Best AM, Gennings C, Burnham EL, Moss M. Alcohol use disorders increase the risk for mechanical ventilation in medical patients. Alcohol Clin Exp Res. 2007 Jul;31(7):1224-30. doi: 10.1111/j.1530-0277.2007.00421.x. Epub 2007 May 20.
- Background: PubMed 17359534de Wit M, Wan SY, Gill S, Jenvey WI, Best AM, Tomlinson J, Weaver MF. Prevalence and impact of alcohol and other drug use disorders on sedation and mechanical ventilation: a retrospective study. BMC Anesthesiol. 2007 Mar 14;7:3. doi: 10.1186/1471-2253-7-3.
- Background: PubMed 17334243Lipiner-Friedman D, Sprung CL, Laterre PF, Weiss Y, Goodman SV, Vogeser M, Briegel J, Keh D, Singer M, Moreno R, Bellissant E, Annane D; Corticus Study Group. Adrenal function in sepsis: the retrospective Corticus cohort study. Crit Care Med. 2007 Apr;35(4):1012-8. doi: 10.1097/01.CCM.0000259465.92018.6E.
- Background: PubMed 12658106Gianoulakis C, Dai X, Brown T. Effect of chronic alcohol consumption on the activity of the hypothalamic-pituitary-adrenal axis and pituitary beta-endorphin as a function of alcohol intake, age, and gender. Alcohol Clin Exp Res. 2003 Mar;27(3):410-23. doi: 10.1097/01.ALC.0000056614.96137.B8.
- Background: PubMed 15318117Kudoh A, Katagai H, Takase H, Takazawa T. Increased cortisol response to surgery in patients with alcohol problems who developed postoperative confusion. Alcohol Clin Exp Res. 2004 Aug;28(8):1187-93. doi: 10.1097/01.alc.0000134229.19493.fc.
- Derived from this study: PubMed 21176217de Wit M, Wiaterek GK, Gray ND, Goulet KE, Best AM, Clore JN, Sweeney LB. Relationship between alcohol use disorders, cortisol concentrations, and cytokine levels in patients with sepsis. Crit Care. 2010;14(6):R230. doi: 10.1186/cc9385. Epub 2010 Dec 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjolein de Wit, MD, MS principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Alcoholism, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00615862, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012; AzTrials last refreshed its copy on 6 Nov 2026.