Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005667
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-05-19
Brief Title:
Vancomycin Resistant Enterococci in Patients Awaiting Liver Transplantation at the University of Michigan Prevalence Risk Factors Natural History and Outcome of Colonization
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000042 | NIH | None | httpsreporternihgovquickSearchM01RR000042 |