Infectious Outcomes Following Pancreas Transplantation - Full Text View

Sponsor:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00332111

Purpose

The proposed protocol aims to characterize the infectious episodes in pancreas transplant recipients under the current medical care. Knowing these patients infectious risks, the types of infections that commonly affect them and the morbidity and mortality associated with it will provide valuable information in the evaluation of the safety and efficacy of the current practices. The information generated by this study will also serve as the basis for development of strategies targeting prophylaxis of infectious episodes.

Condition
Pancreatic Transplantation

Study Type:	Observational
Study Design:	Prospective
Official Title:	Infectious Outcomes Following Pancreas Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Pancreas Transplantation

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.

Estimated Enrollment:	300
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2012
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Detailed Description:

The objectives of the study are:

To determine what is the frequency of infectious complications following pancreas transplantation
Characterize the clinical and microbiological aspects of the infectious complications following pancreas transplantation
Identify predictors for infection following pancreas transplantation
Determine the frequency of graft loss and associated mortality of infectious complications following pancreas transplantation

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 with pancreatic and kidney transplants

Criteria

Inclusion Criteria:

Patients who underwent pancreas with or without kidney transplantation at the University of Pittsburgh Medical Center from January 1st 2002 to December 31st 2005
Patients must be above 18 years of age
Patients undergoing retransplantation may be included.

Exclusion Criteria:

History of pancreas transplantation at another institution

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332111

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Fernanda Silveira, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	UPMC ( Fernanda Silveira, MD )
Study ID Numbers:	IRB# 0603103
Study First Received:	May 30, 2006
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00332111 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

transplant
pancreas

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Pancrelipase
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010