Impact of Gender on Patients
Condition: Hospital-acquired Infections
MeSH terms: Infections
Study type: Observational

Summary: 
      The purpose of this study is to better understand the relationship between gender (being a
      man or a woman), infections caught in the hospital, and serious illness. Five hundred seventy
      patients 18 years of age or older who are critically (seriously) ill and admitted to the
      Intensive Care Unit (ICU) for at least 48 hours will participate in this study. Patients will
      be studied while receiving regular ICU treatment according to local standards. Blood
      specimens will come from patients either as wasted blood (University of Virginia) or blood
      collected from patients specifically for the study (Vanderbilt University). All patients will
      be followed daily until death or discharge from the ICU. The researchers believe that they
      will find a similar risk of infection for men and women overall.
    

Detailed description: 
      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.
    

Time perspective: Prospective
Keywords: hospital, acquired, infections, mortality