Critical IllnessNCT00843557
Impact of Gender on Hospitalized Patients
An observational study of Critical Illness, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 2,400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Apr 2008
- 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: Patients admitted to general surgery and trauma ICU
Who may be able to join
- 1. All patients >= 18 years old admitted to the ICU for >= 48 hours.
Who cannot join
- Age < 18 years old.
- Death or discharge within 48 hours of ICU admission.
- Patients not on a surgical service.
- Patients admitted with a primary diagnosis of burns.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
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.
Read the 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.
- Conditions
- Critical Illness
- Keywords
- critical illness, intensive care, nosocomial infection
- Medical subject headings
- Critical Illness, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all ICU admissions | patients admitted to the ICU for greater then 72hrs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death following admission to the ICU
Measured: duration of hospitalization
Secondary outcomes (1)
incidence of infection of patients treated in the ICU
Measured: duration of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startSep 2001
- Primary completionMay 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Investigators
- Robert G Sawyer, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843557
- Sponsor's protocol ID
- 9481
- Other IDs
- 00170560
- Status last verified
- Oct 2016
- First submitted
- 12 Feb 2009
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gender on Hospitalized Patients
- ClinicalTrials.gov ID
- NCT00843557
- Acronym / sponsor ID
- 9481
- Conditions
- Critical Illness
- Keywords
- critical illness, intensive care, nosocomial infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- Sep 2001
- Primary completion
- May 2006 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Feb 2009 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all ICU admissions | – | –patients admitted to the ICU for greater then 72hrs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to general surgery and trauma ICU
Key inclusion criteria (1 listed)
- 1. All patients >= 18 years old admitted to the ICU for >= 48 hours.
Key exclusion criteria (4 listed)
- Age < 18 years old.
- Death or discharge within 48 hours of ICU admission.
- Patients not on a surgical service.
- Patients admitted with a primary diagnosis of burns.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death following admission to the ICU
Time frame: duration of hospitalization
1 secondary outcome
incidence of infection of patients treated in the ICU
Time frame: duration of hospitalization
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 27 Oct 2016.
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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.
Robert G Sawyer, MD principal investigator
University of Virginia
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 Critical Illness, run by University of Virginia 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 4 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 27 Oct 2016. 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?
Death following admission to the ICU (time frame: duration of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.