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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
History of Changes

May 30, 2006
January 15, 2013
April 2006
September 2008   (final data collection date for primary outcome measure)
30 day outcomes after transplantation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
outcomes of transplant patients post transplant
Not Provided
Complete list of historical versions of study NCT00332111 on ClinicalTrials.gov Archive Site
Not Provided
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Infectious Outcomes Following Pancreas Transplantation
Infectious Outcomes Following Pancreas Transplantation

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.

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
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
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.
Non-Probability Sample

patients with pancreatic and kidney transplants
Pancreatic Transplantation
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00332111
IRB# 0603103
Yes
University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Fernanda Silveira, MD University of Pittsburgh
University of Pittsburgh
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP