Functional Reserve Estimation of Donor Kidney
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|ClinicalTrials.gov Identifier: NCT01689272|
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : February 11, 2015
The purpose of the study:
- To estimate the role of morphological, clinical, biochemical and imaging studies at stages of kidney transplantation (medical therapy, explantation, preservation, transplantation).
- To improve the ways of preserving optimal functional parameters of renal transplants.
|Condition or disease||Intervention/treatment||Phase|
|End-stage Renal Disease||Procedure: Kidney Transplantation from alive relative donor||Phase 4|
Terminal chronic renal failure (ESRD) as a result of almost any chronic kidney disease develops due to progressive loss of nephrons. This state is characterized by a gradual deterioration of the functional abilities of not only the kidneys, but also the whole body. Currently, ESRD is among the first ten causes of mortality .
Transplantation of donor organs is the only radical treatment for various diseases of the terminal, for patients with a fatal prognosis.
Kidney transplantation has allowed not only save lives, but also to return to normal life, tens of thousands of people. Survival of renal transplant recipients is growing.
Despite the progress made in many clinics worldwide in recent years in the field of transplantation, kidney transplantation, does not settle the problem of reperfusion injury and the associated post-transplant dysfunction with the absence of clear indicators of morphological, clinical, biochemical and instrumental methods to assess functional reserve of organs that remain relevant and meaningful.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving of Morphological,Clinical Biochemical and Instrumental Functional Reserve Estimation of Donor Kidney|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2013|
Experimental: Kidney transplantation
Kidney transplantation from alive relative donor.
Procedure: Kidney Transplantation from alive relative donor
Donor kidney sampling, preservation, transport and transplantation
- Functional Reserve Estimation of Donor Kidney [ Time Frame: for 12 months ]
Graft survival is assessed on the following criteria:
- The duration of the functioning graft
- Clinical, laboratory and device functioning graft.
- Morphological and histological study of the stages of transplantation (for withdrawal, before implantation) and the post-transplant period (with the threat of rejection.) Study of the blood recipient: Laboratory tests of blood recipient: biochemical analysis, the composition of the electrolyte, acid-base status, the level of immunosuppressants. Immunological typing for HLA-system. Cross-typing of donor and recipient, the level of pre-existing limfotsitotoksicheskih antibodies in the recipient.Patients survival.
- Clinical and Laboratory,Imaging Parameters [ Time Frame: From 2 hours to 7 days ]
- Intraoperational Macroscopic Description of signs of kidney ischemia: turgor, colour, consistency of transplanted kidney, pulse characteristics of renal artery.
- Signs of graft rejection: increasing of temperature, blood pressure, the levels of waste products (blood creatinine, blood urea).
- Pre-Operative Patients Health Status: Donor and Recipient [ Time Frame: For 1 week ]
- Patient-donor health status.
- Concomitant somatic pathology of a patient-recipient.
- Time for Kidney transplantation.
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 ClinicalTrials.gov identifier (NCT number): NCT01689272
|Republican Scientific Center for Emergency Medicine|
|Astana, Kazakhstan, 010000|
|Principal Investigator:||Gani M Kuttymuratov, Phd||Advisor to the Board Chairman|