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The Role of Reactive Oxygen Species in Ischaemia-Reperfusion Injury of the Transplanted Kidney

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.
 
ClinicalTrials.gov Identifier: NCT00204178
Recruitment Status : Unknown
Verified August 2005 by Uniwersytet Mikolaja Kopernika w Toruniu.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : December 1, 2005
Sponsor:
Information provided by:
Uniwersytet Mikolaja Kopernika w Toruniu

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 20, 2005
Last Update Posted Date December 1, 2005
Study Start Date April 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Role of Reactive Oxygen Species in Ischaemia-Reperfusion Injury of the Transplanted Kidney
Official Title The Role of Reactive Oxygen Species in Ischaemia-Reperfusion Injury of the Transplanted Kidney
Brief Summary Measurement of reactive oxygen species production and antioxidant system status before and directly after reperfusion of the transplanted kidney and influence of oxidant stress on kidney function in 2 and 6 weeks.
Detailed Description

Oxidative stress is one of the most important factors in ischaemia-reperfusion injury to the transplanted organ. In kidney transplant recipients following factors were measured: glutathione level, activities of glutathione peroxidase (GSH-PX), catalase (CAT) and superoxide dismutase (SOD) and superoxide anion production by granulocytes in whole blood without and after the stimulation with zymosan.

Blood was sampled from peripheral vein (before reperfusion) and directly from renal vein (5 and 15 minutes after reperfusion).

Transplanted kidney function was evaluated by the incidence and length of Delayed Graft Function and serum creatinine level in 2 and 6 weeks after transplantation.

Study Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Kidney Transplantation
Intervention Behavioral: Oxidative stress in kidney transplant recipients
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: September¬†13,¬†2005)
60
Original Enrollment Same as current
Study Completion Date September 2005
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • consecutive patients accepted for and undergoing cadaveric kidney transplantation

Exclusion Criteria:

  • no informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00204178
Other Study ID Numbers KB/38/2003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Uniwersytet Mikolaja Kopernika w Toruniu
Collaborators Not Provided
Investigators
Study Director: Zbigniew Wlodarczyk, MD,PhD Klinika Transplantologii Collegium Medicum UMK w Toruniu
PRS Account Uniwersytet Mikolaja Kopernika w Toruniu
Verification Date August 2005