Impact of Gender on Hospitalized Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Virginia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Vanderbilt University
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00843557
First received: February 12, 2009
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

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.


Condition
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Death following admission to the ICU [ Time Frame: duration of hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of infection of patients treated in the ICU [ Time Frame: duration of hospitilization ] [ Designated as safety issue: No ]

Enrollment: 2400
Study Start Date: September 2001
Estimated Study Completion Date: April 2010
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
all ICU admissions
patients admitted to the ICU for greater then 72hrs

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to general surgery and trauma ICU

Criteria

Inclusion Criteria: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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843557

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Vanderbilt University
Investigators
Principal Investigator: Robert G Sawyer, MD University of Virginia
  More Information

No publications provided

Responsible Party: Robert G. Sawyer MD, Universtiy of Virginia
ClinicalTrials.gov Identifier: NCT00843557     History of Changes
Other Study ID Numbers: 9481, 00170560
Study First Received: February 12, 2009
Last Updated: September 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
critical illness
intensive care
nosocomial infection

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014