COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Infectious Outcomes Following Pancreas Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332111
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : January 17, 2013
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
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 or disease
Pancreatic Transplantation

Detailed Description:

The objectives of the study are:

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Infectious Outcomes Following Pancreas Transplantation
Study Start Date : April 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 30 day outcomes after transplantation [ Time Frame: 30 days ]
    outcomes of transplant patients post transplant

Biospecimen Retention:   Samples Without DNA
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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with pancreatic and kidney transplants

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332111

Layout table for location information
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Layout table for investigator information
Principal Investigator: Fernanda Silveira, MD University of Pittsburgh

Layout table for additonal information
Responsible Party: University of Pittsburgh Identifier: NCT00332111    
Other Study ID Numbers: IRB# 0603103
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013
Keywords provided by University of Pittsburgh:
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Gastrointestinal Agents