Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001358730
Ethics application status
Approved
Date submitted
25/11/2013
Date registered
11/12/2013
Date last updated
11/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The importance of microcirculation and pathophysiological role of endothelin-1 in kidney transplantation
Scientific title
The importance of microcirculation and pathophysiological role of endothelin-1 in kidney transplantation
Secondary ID [1] 283651 0
Nil
Universal Trial Number (UTN)
U1111-1150-7480
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing kidney Transplantation 290601 0
Condition category
Condition code
Inflammatory and Immune System 290987 290987 0 0
Other inflammatory or immune system disorders
Surgery 290988 290988 0 0
Other surgery
Renal and Urogenital 290989 290989 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Twenty patients undergoing kidney transplantation will be included in the study. Data regarding preoperative variables, intraoperative and postoperative variables (delayed graft function, rejection), are prospectively collected. Patients will be followed up for 30 days
A non-invasive device (called Sidestream Dark Field imaging), that allow for clinical observation of the microcirculation will be used 30 minutes after kidney reperfusion.
It is hand-held probe with a sterile extension for direct contact with renal parenchyma. The tissue to be acquired in this study will be obtained from surgical specimens taken from consented participants having renal transplant.
Intervention code [1] 288353 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290972 0
Correlation between microcirculation and kidney transplant outcome.
Role of endothelin-1
Timepoint [1] 290972 0
Post transplant outcome
Secondary outcome [1] 305708 0
Renal function, serum marker such as creatinine, GFR, IL-18
Timepoint [1] 305708 0
Post operative days, 1,2,5 ,7

Eligibility
Key inclusion criteria
patients undergoing kidney transplant
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who did not agree to be included in the study

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1762 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 7581 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 288329 0
Hospital
Name [1] 288329 0
Royal Prince Alfred Transplant Institute
Country [1] 288329 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Transplant Institute
Address
missenden road, camperdown, nsw, 2050
Country
Australia
Secondary sponsor category [1] 287045 0
None
Name [1] 287045 0
Address [1] 287045 0
Country [1] 287045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290221 0
Royal Prince Alfred Hospital research development office
Ethics committee address [1] 290221 0
missenden road, camperdown, nsw, 2050
Ethics committee country [1] 290221 0
Australia
Date submitted for ethics approval [1] 290221 0
Approval date [1] 290221 0
22/11/2013
Ethics approval number [1] 290221 0
hrec/13/rpah/89

Summary
Brief summary
Twenty patients undergoing kidney transplant will be included in the study. Data regarding preoperative variables, intraoperative and postoperative variables are prospectively collected.
A non-invasive device (called Sidestream Dark Field imaging), that allow for clinical observation of the microcirculation will be used.
It is hand-held probe with a sterile extension for direct contact with renal parenchyma.
kidney biopsies are performed to assess Immunohystochemical intensity of ET-1 and other markers. The tissue to be acquired in this study will be obtained from surgical specimens taken from consented participants having kidney transplant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44534 0
Dr Carlo Pulitano
Address 44534 0
Royal Prince Alfred hospital, missenden road
camperdown 2050, NSW
Country 44534 0
Australia
Phone 44534 0
+61 2 951 53452
Fax 44534 0
Email 44534 0
[email protected]
Contact person for public queries
Name 44535 0
Dr Carlo Pulitano
Address 44535 0
Royal Prince Alfred hospital, missenden road
camperdown 2050, NSW
Country 44535 0
Australia
Phone 44535 0
+61 2 951 53452
Fax 44535 0
Email 44535 0
[email protected]
Contact person for scientific queries
Name 44536 0
Dr Carlo Pulitano
Address 44536 0
Royal Prince Alfred hospital, missenden road
camperdown 2050, NSW
Country 44536 0
Australia
Phone 44536 0
+61 2 951 53452
Fax 44536 0
Email 44536 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.