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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030305
Receipt No. R000034582
Scientific Title Remote ischemic preconditioning for renal protection during partial nephrectomy
Date of disclosure of the study information 2018/01/04
Last modified on 2019/06/13

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Basic information
Public title Remote ischemic preconditioning for renal protection during partial nephrectomy
Acronym RIPC in partial nephrectomy
Scientific Title Remote ischemic preconditioning for renal protection during partial nephrectomy
Scientific Title:Acronym RIPC in partial nephrectomy
Region
Japan

Condition
Condition Kidney Neoplasm
Classification by specialty
Nephrology Urology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the renal protective effect of remote ischemic preconditioning in patients undergoing partial nephrectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The nadir estimated glomerular filtration rate (mL/min/1.73m2) within 7 days of operation
Key secondary outcomes The incidence of acute kidney injury; Estimated glomerular filtration rate (mL/min/1.73m2) at 1, 3 and 6 months after operation; Operation time; Ischemic time; Estimated blood loss; Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 After induction of anesthesia and before clamping of the renal artery, we perform remote ischemic preconditioning consisting of 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mmHg to one lower limb, followed by 5-minute reperfusion with the cuff deflated.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients with estimated glomerular filtration rate >= 30 mL/min/1.73m2 who give written informed consent and are scheduled to undergo open or robot-assisted laparoscopic partial nephrectomy for the renal mass with diameter >= 40 mm or RENAL nephrometry score >= 10.
Key exclusion criteria 1. No limbs
2. Peripheral vascular disease affecting lower limbs
3. Peripheral nerve injury affecting lower limbs
4. Bleeding tendency
5. Cognitive disorder
6. Mental disorder requiring treatment
7. Poorly controlled diabetes (HbA1c >= 7.0%)
8. Drug therapy with sulfonamide or nicorandil
9. Pregnancy
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kazunari
Middle name
Last name Tanabe
Organization Tokyo Women's Medical University
Division name Department of Urology
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email tanabe@twmu.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Omae
Organization Tokyo Women's Medical University
Division name Department of Urology
Zip code 1628666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email omae416@fmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Institute for Health Outcomes and Process Evaluation research (iHope International)
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 The Institutional Review Board of Tokyo Womens Medical University
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
Tel 03-5269-7832
Email rinri.bm@twmu.ac.jp

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 01 Month 04 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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 02 Day
Date of IRB
2017 Year 11 Month 02 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 08 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034582

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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