Vancomycin Resistant Enterococci in Patients Awaiting Liver Transplantation at the University of Michigan: Prevalence, Risk Factors, Natural History and Outcome of Colonization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00005667
First received: May 19, 2000
Last updated: June 23, 2005
Last verified: November 2001
  Purpose

Enterococci, especially vancomycin resistant enterococci (VRE), are increasing in prevalence in many hospitals in the United States. Patients undergoing liver transplantation are at particular risk for developing infection due to VRE. The effect of prior colonization with VRE on the outcome of liver transplantation is unknown. This prospective study will ascertain the prevalence of gastrointestinal colonization with vancomycin resistant enterococci among patients awaiting liver transplantation at the University of Michigan Health System. Risk factors for acquisition of the organism, natural history of colonization and outcome in colonized patients will also be determined. All patients currently listed on a priority waiting list for liver transplantation at UMHS will be invited to participate. Patients will receive a standardized letter from their primary gastroenterologist describing the rationale for the study. Patients will be contacted by telephone by a member of the study team in order to arrange an appointment in the GCRC at the time of their regularly scheduled Transplant Clinic appointment in order discuss their potential participation in the study. Patients who give informed consent, will be interviewed using a standard interview questionnaire. Demographic and historical data relevant to the risk of VRE colonization will be collected during the interview. A sample will be obtained via rectal swab for culture. Rectal swabs for culture and collection of information on the standardized questionnaire will be repeated every six months while the patient is awaiting liver transplantation. When a patient undergoes liver transplantation, a culture will be obtained at the time of admission and weekly after post-operatively until discharge. All patients will be followed for 60 days after transplantation to assess several primary outcomes, including operative and post-operative complications, VRE infection and mortality. Rectal swabs will be the only procedure performed for the purposes of this study. Culture results will not be made available to the transplant team in order to avoid bias in clinical care. All data will be entered into an electronic database. GCRC statisticians will assist in the analysis of risk factors and outcome analysis.


Condition
Liver Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients 18 years or older currently listed on a priority waiting list for liver transplantation at the University of Michigan will be invited to participate.
  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: NCT00005667

Locations
United States, Michigan
3316 Taubman Center, Box 0378 1500 E Medical Center Drive
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00005667     History of Changes
Other Study ID Numbers: NCRR-M01RR00042-1658, M01RR00042
Study First Received: May 19, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
liver transplantation
vancomycin resistance

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014