Impact of Gender on Patients

The purpose of this study is to gain knowledge that will be used to design further
interventional studies to better define beneficial therapies related to gender, infection,
and critical illness, such as modulation of hormone levels in a sex-specific manner. This is
a two-year observational study in which approximately a total of 570 patients will be
enrolled. All patients will be 18 years of age or older and admitted to the Intensive Care
Unit (ICU) for at least 48 hours. Patients will be studied while receiving accepted and
approved therapy according to local standards. Data obtained will be that which would
normally be considered part of a standard complete medical history. Specimens will come from
patients either as wasted blood (University of Virginia) or blood drawn from patients
specifically for this purpose (Vanderbilt University). The maximum blood removed will be 30
ml twice weekly and is considered a minor risk. All specimens analyzed, regardless of
institution, are done so in a blinded manner, identified only by study number and specimen
number or through password and encryption protected servers when communicated electronically.
Since the cohort is comprised of all patients admitted to an ICU, recruitment in the normal
sense is not practical. An initial comparison of demographic data, severity of illness,
frequency of comorbidities, hormone and cytokine levels, and outcome variables will be
compared between males and females treated for infection. All patients will be followed daily
until death or discharge from the ICU. It is anticipated that a similar risk of infection for
men and women overall will be determined. Specific Aim I of the study is to prospectively
determine and compare the incidence of and associated mortality from hospital-acquired
infections in a large, critically-ill population of pre-menopausal women, post-menopausal
women, and men after controlling for multiple pre-defined confounding variables. The Specific
Aim II of the study is to determine the relationship between sex hormonal status, systemic
cytokine levels, and the incidence of and outcome from hospital-acquired infections, as well
as the relative contribution of infection and end-of-life decisions to outcome in subjects
dying under study.

Inclusion Criteria:

1. All patients >= 18 years old admitted to the ICU for >= 48 hours.

Exclusion Criteria:

1. Age < 18 years old.

2. Death or discharge within 48 hours of ICU admission.

3. Patients not on a surgical service.

4. Patients admitted with a primary diagnosis of burns.