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

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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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name