Infectious Outcomes Following Pancreas Transplantation

January 15, 2013 updated by: University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with pancreatic and kidney transplants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day outcomes after transplantation
Time Frame: 30 days
outcomes of transplant patients post transplant
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (Estimate)

June 1, 2006

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 0603103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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