Sepsis Clinical Trial
Official title:
Relationship Between Alcohol Use Disorders and Cortisol Levels in Patients With Sepsis
Verified date | June 2009 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia) | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
de 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. Epub 2007 May 20. — View Citation
de 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. — View Citation
Gianoulakis 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. — View Citation
Kudoh 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. — View Citation
Lipiner-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. — View Citation
Moss 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Within 24 hours of hospital admission | No | |
Secondary | 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. | Within 24 hours of hospital admission | No | |
Secondary | 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. | Within 72 hours of hospital admission | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05095324 -
The Biomarker Prediction Model of Septic Risk in Infected Patients
|
||
Completed |
NCT02714595 -
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
|
Phase 3 | |
Completed |
NCT03644030 -
Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
|
||
Completed |
NCT02867267 -
The Efficacy and Safety of Ta1 for Sepsis
|
Phase 3 | |
Completed |
NCT04804306 -
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
|
||
Recruiting |
NCT05578196 -
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
|
N/A | |
Terminated |
NCT04117568 -
The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
|
||
Completed |
NCT03550794 -
Thiamine as a Renal Protective Agent in Septic Shock
|
Phase 2 | |
Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
Completed |
NCT04227652 -
Control of Fever in Septic Patients
|
N/A | |
Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
Recruiting |
NCT04005001 -
Machine Learning Sepsis Alert Notification Using Clinical Data
|
Phase 2 | |
Completed |
NCT03258684 -
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock
|
N/A | |
Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
Completed |
NCT05018546 -
Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery
|
N/A | |
Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
Not yet recruiting |
NCT06045130 -
PUFAs in Preterm Infants
|
||
Not yet recruiting |
NCT05361135 -
18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia
|
N/A | |
Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 |