NCT00170560

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
635

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

February 4, 2019

Status Verified

October 1, 2007

First QC Date

September 13, 2005

Last Update Submit

January 31, 2019

Conditions

Hospital-acquired Infections

Keywords

hospital, acquired, infections, mortality

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

University of Virginia

Charlottesville, Virginia, 22906, United States

Location

Related Publications (10)

  • Guidry CA, Swenson BR, Davies SW, Dossett LA, Popovsky KA, Bonatti H, Evans HL, Metzger R, Hedrick TL, Tache-Leon CA, Hranjec T, Chaudry IH, Pruett TL, May AK, Sawyer RG. Sex- and diagnosis-dependent differences in mortality and admission cytokine levels among patients admitted for intensive care. Crit Care Med. 2014 May;42(5):1110-20. doi: 10.1097/CCM.0000000000000139.

    PMID: 24365862DERIVED

  • Heffernan DS, Dossett LA, Lightfoot MA, Fremont RD, Ware LB, Sawyer RG, May AK. Gender and acute respiratory distress syndrome in critically injured adults: a prospective study. J Trauma. 2011 Oct;71(4):878-83; discussion 883-5. doi: 10.1097/TA.0b013e31822c0d31.

    PMID: 21986736DERIVED

  • Kauffmann RM, Norris PR, Jenkins JM, Dupont WD, Torres RE, Blume JD, Dossett LA, Hranjec T, Sawyer RG, May AK. Trends in estradiol during critical illness are associated with mortality independent of admission estradiol. J Am Coll Surg. 2011 Apr;212(4):703-12; discussion 712-3. doi: 10.1016/j.jamcollsurg.2010.12.017.

    PMID: 21463817DERIVED

  • Hranjec T, Swenson BR, Dossett LA, Metzger R, Flohr TR, Popovsky KA, Bonatti HJ, May AK, Sawyer RG. Diagnosis-dependent relationships between cytokine levels and survival in patients admitted for surgical critical care. J Am Coll Surg. 2010 May;210(5):833-44, 845-6. doi: 10.1016/j.jamcollsurg.2009.12.042.

    PMID: 20421061DERIVED

  • Collier B, Dossett L, Shipman J, Day M, Lawson G, Sawyer R, May A. Visceral adiposity is not associated with inflammatory markers in trauma patients. J Trauma. 2010 Jan;68(1):57-61. doi: 10.1097/TA.0b013e3181c40262.

    PMID: 20065758DERIVED

  • Dossett LA, Redhage LA, Sawyer RG, May AK. Revisiting the validity of APACHE II in the trauma ICU: improved risk stratification in critically injured adults. Injury. 2009 Sep;40(9):993-8. doi: 10.1016/j.injury.2009.03.004. Epub 2009 Jun 16.

    PMID: 19535054DERIVED

  • Dossett LA, Dageforde LA, Swenson BR, Metzger R, Bonatti H, Sawyer RG, May AK. Obesity and site-specific nosocomial infection risk in the intensive care unit. Surg Infect (Larchmt). 2009 Apr;10(2):137-42. doi: 10.1089/sur.2008.028.

    PMID: 19388836DERIVED

  • Dossett LA, Swenson BR, Evans HL, Bonatti H, Sawyer RG, May AK. Serum estradiol concentration as a predictor of death in critically ill and injured adults. Surg Infect (Larchmt). 2008 Feb;9(1):41-8. doi: 10.1089/sur.2007.037.

    PMID: 18363467DERIVED

  • Dossett LA, Swenson BR, Heffernan D, Bonatti H, Metzger R, Sawyer RG, May AK. High levels of endogenous estrogens are associated with death in the critically injured adult. J Trauma. 2008 Mar;64(3):580-5. doi: 10.1097/TA.0b013e31816543dd.

    PMID: 18332796DERIVED

  • May AK, Dossett LA, Norris PR, Hansen EN, Dorsett RC, Popovsky KA, Sawyer RG. Estradiol is associated with mortality in critically ill trauma and surgical patients. Crit Care Med. 2008 Jan;36(1):62-8. doi: 10.1097/01.CCM.0000292015.16171.6D.

    PMID: 18090358DERIVED

MeSH Terms

Conditions

Infections

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

October 1, 2001

Last Updated

February 4, 2019

Record last verified: 2007-10

Locations

US(2)