Infectious Outcomes Following Pancreas Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00332111
First received: May 30, 2006
Last updated: January 15, 2013
Last verified: January 2013
  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: Time Perspective: Prospective
Official Title: Infectious Outcomes Following Pancreas Transplantation

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 30 day outcomes after transplantation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 300
Study Start Date: April 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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
  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
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: 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: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00332111     History of Changes
Other Study ID Numbers: IRB# 0603103
Study First Received: May 30, 2006
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
transplant
pancreas

Additional relevant MeSH terms:
Communicable Diseases
Infection
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014