The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy

NCT ID: NCT03273751

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-08-28

Brief Summary

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This study is intended to evaluate the renal protective effect of Remote Ischemic Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction and prior to the surgery, while the other half will not receive this treatment as a control group.

Detailed Description

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Remote Ischemic Preconditioning (RIPC) is the concept of mitigating ischemia-reperfusion injury to target organs by a brief episode of ischemia-reperfusion of the limb. The protective effect of RIPC on major organs has been demonstrated in an animal study, but its clinical efficacy has not yet been established.

The kidney is a typical organ vulnerable to ischemic injury, and the renal protective effect of RIPC can be expected. There have been many reports of renal protective effects of RIPC in cardiac and vascular surgery. On the other hand, few studies have investigated the effect of RIPC during partial nephrectomy in which ischemia-reperfusion injury can occur during the surgery.

In this study, the investigators will evaluate the effect of RIPC in patients undergoing partial nephrectomy to prevent renal impairment and improve the prognosis after the surgery.

Conditions

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Renal Neoplasm Renal Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, randomized, parallel group, controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Participants, care providers, investigators and outcome assessors will be blinded to group allocation.

Study Groups

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Remote Ischemic Preconditioning (RIPC)

Four cycles of upper arm ischemia/reperfusion

Group Type EXPERIMENTAL

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

After induction of anesthesia, RIPC consisted of four 5-min cycles of limb ischemia induced by a blood pressure cuff placed on the upper arm and inflated to 250 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Sham control

Placement of a blood pressure cuff around upper arm without inflation.

Group Type SHAM_COMPARATOR

Sham control

Intervention Type PROCEDURE

After induction of anesthesia, sham control consisted of the placement of a blood pressure cuff on the upper arm with no inflation during the surgery.

Interventions

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Remote Ischemic Preconditioning

After induction of anesthesia, RIPC consisted of four 5-min cycles of limb ischemia induced by a blood pressure cuff placed on the upper arm and inflated to 250 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Intervention Type PROCEDURE

Sham control

After induction of anesthesia, sham control consisted of the placement of a blood pressure cuff on the upper arm with no inflation during the surgery.

Intervention Type PROCEDURE

Other Intervention Names

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RIPC

Eligibility Criteria

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Inclusion Criteria

* Adult patients scheduled to undergo open, laparoscopic, or robot-assisted laparoscopic partial nephrectomy
* Normal contralateral renal function was defined as split renal function of \>40% as determined by preoperative Tc-99m DiethyleneTriamine Pentaacetic Acid (DTPA) kidney scan
* Written informed consent

Exclusion Criteria

* Peripheral vascular disease involving upper extremities or lower extremities
* Severe cardiopulmonary diseases (valvular or ischemic heart disease, heart failure, chronic obstructive pulmonary disease)
* Hepatic failure, renal failure
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Won Ho Kim, MD

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Ho Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Huang J, Chen Y, Dong B, Kong W, Zhang J, Xue W, Liu D, Huang Y. Effect of remote ischaemic preconditioning on renal protection in patients undergoing laparoscopic partial nephrectomy: a 'blinded' randomised controlled trial. BJU Int. 2013 Jul;112(1):74-80. doi: 10.1111/bju.12004. Epub 2013 Mar 4.

Reference Type BACKGROUND
PMID: 23452148 (View on PubMed)

Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189.

Reference Type BACKGROUND
PMID: 26024502 (View on PubMed)

Zhang L, Diao Y, Chen G, Tanaka A, Eastwood GM, Bellomo R. Remote ischemic conditioning for kidney protection: A meta-analysis. J Crit Care. 2016 Jun;33:224-32. doi: 10.1016/j.jcrc.2016.01.026. Epub 2016 Feb 10.

Reference Type BACKGROUND
PMID: 26936039 (View on PubMed)

Hur M, Park SK, Shin J, Choi JY, Yoo S, Kim WH, Kim JT. The effect of remote ischemic preconditioning on serum creatinine in patients undergoing partial nephrectomy: a study protocol for a randomized controlled trial. Trials. 2018 Sep 4;19(1):473. doi: 10.1186/s13063-018-2820-3.

Reference Type DERIVED
PMID: 30180887 (View on PubMed)

Other Identifiers

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1707-087-870

Identifier Type: -

Identifier Source: org_study_id