UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034766 |
|---|---|
| Receipt number | R000039651 |
| Scientific Title | Blood pressure management after reperfusion in living-donor renal transplantation |
| Date of disclosure of the study information | 2018/11/05 |
| Last modified on | 2018/11/05 12:39:58 |
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Basic information
Public title
Blood pressure management after reperfusion in living-donor renal transplantation
Acronym
Blood pressure management after reperfusion in living-donor renal transplantation
Scientific Title
Blood pressure management after reperfusion in living-donor renal transplantation
Scientific Title:Acronym
Blood pressure management after reperfusion in living-donor renal transplantation
Region
| Japan |
Condition
Condition
Recipient of living-donor renal transplantation
Classification by specialty
| Nephrology | Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of SBP after reperfusion on early graft function in living-donor renal transplantation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Renal function in the first seven postoperative days was the primary outcomes in this study.
Key secondary outcomes
Urine output after reperfusion and postoperative course were investigated.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent living-donor renal transplantation
Key exclusion criteria
Under 18 years old.
Intraoperative massive bleeding (>2,000ml).
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Karashima |
Organization
Kyushu University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
+81926425714
ykara@kuaccm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Kawasaki |
Organization
Kyushu University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
+81926425714
Homepage URL
skwsk@kuaccm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We divided the patients into four groups according to SBP after reperfusion ( <140, 140-149, 150-159 and >=160 mmHg) to evaluate the influence on early graft function in living-donor renal transplantation.
Management information
Registered date
| 2018 | Year | 11 | Month | 05 | Day |
Last modified on
| 2018 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039651
