UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030305 |
|---|---|
| Receipt number | 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 | 2023/05/24 08:46:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
omae416@fmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
Fukushima Medical University
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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034582
Publication of results
Published
Result
URL related to results and publications
https://rdcu.be/dcKoe
Number of participants that the trial has enrolled
59
Results
Of the 59 patients with RIPC and 482 without RIPC, 53 each were matched by propensity score. There were no significant differences in the postoperative eGFR in mL/min/1.73m2 at nadir (mean difference 3.8, 95% CI -2.8-10.4) and its % change from baseline (mean difference 4.7, 95% CI -1.6-11.1) between the two groups. The sensitivity analysis also showed no significant differences.
Results date posted
| 2022 | Year | 12 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 05 | Month | 23 | Day |
Baseline Characteristics
The mean age of the RIPC and non-RIPC groups was 60.4 and 59.7 years, respectively; the percentages of men were 64.4% and 73.0%, respectively; mean BMI was 26.0 and 25.0, respectively; and preoperative eGFR was 65.8 mL/min/1.73m2 and 64.9 mL/min/1.73m2, respectively.
Participant flow
Fifty-nine patients with a solitary renal tumor who underwent RAPN with RIPC consisting of three 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 from 2018 to 2020 were included in the analysis. Patients who underwent RAPN for a solitary renal tumor without RIPC from 2018 to 2020 were selected as controls.
Adverse events
While no significant differences were observed in warm ischemia time, estimated blood loss, open conversion, complication, positive surgical margin, and benign tumor, the RIPC group had a longer postoperative length of hospital stays than the control group (mean difference 1.3 days, 95% CI 0.09-2.5). No complications were associated with the RIPC procedure.
Outcome measures
Postoperative renal function was measured one day, three days, one month, and six months postoperatively as well as at discharge. The primary outcome was the postoperative eGFR at the nadir during hospitalization.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034582
