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

Study Overview
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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.

Official Title
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The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy : A Randomized Controlled Trial

Conditions
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Renal Neoplasm, Renal Injury

Intervention / Treatment
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* Procedure: Remote Ischemic Preconditioning
* Procedure: Sham control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, randomized, parallel group, controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Ischemic Preconditioning (RIPC)<br>Four cycles of upper arm ischemia/reperfusion | Procedure: Remote Ischemic Preconditioning<br>* 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.<br>* Other names: RIPC;|
| Sham Comparator: Sham control<br>Placement of a blood pressure cuff around upper arm without inflation. | Procedure: Sham control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine level | Postoperative serum creatinine levels as an index of kidney damage | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of acute kidney injury (AKI) | The incidence of AKI according to the serum creatinine diagnostic criteria of Kidney Disease Improving Global outcomes (KDIGO) Clinical Practice Guideline for AKI | Within 7 days after surgery | 
| Serum creatinine level | Postoperative serum creatinine levels as an index of kidney damage | 1 hour after surgery | 
| Serum creatinine level | Postoperative serum creatinine levels as an index of kidney damage | Postoperative day 3 | 
| Serum creatinine level | Postoperative serum creatinine levels as an index of kidney damage | 2 weeks after surgery | 
| estimated glomerular filtration rate (eGFR) | eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD). | 1 hour after surgery | 
| estimated glomerular filtration rate (eGFR) | eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD). | Postoperative day 1 | 
| estimated glomerular filtration rate (eGFR) | eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD). | Postoperative day 3 | 
| estimated glomerular filtration rate (eGFR) | eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD). | 2 weeks after surgery | 
| Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side | Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy. | 5 min after the induction of anesthesia (baseline) | 
| Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side | Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy. | 30 minutes after induction of anesthesia | 
| Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side | Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy. | 60 minutes after induction of anesthesia | 
| Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side | Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy. | 90 minutes after induction of anesthesia | 
| Urine creatinine level | Urine creatinine level | Postoperative day 1 | 
| Urine creatinine level | Urine creatinine level | 2 weeks after surgery | 
| Urine microalbumin | Urine microalbumin | Postoperative day 1 | 
| Urine microalbumin | Urine microalbumin | 2 weeks after surgery | 
| Urine beta-2 microglobulin | Urine beta-2 microglobulin | Postoperative day 1 | 
| Urine beta-2 microglobulin | Urine beta-2 microglobulin | 2 weeks after surgery | 
| Urine N-acetyl-beta-D-glucosaminidase | Urine N-acetyl-beta-D-glucosaminidase | Postoperative day 1 | 
| Urine N-acetyl-beta-D-glucosaminidase | Urine N-acetyl-beta-D-glucosaminidase | 2 weeks after surgery | 
| Glomerular filtration rate measured by scintigraphy | Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy | preoperative baseline | 
| Glomerular filtration rate measured by scintigraphy | Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy | 6 months after surgery | 
| Glomerular filtration rate measured by scintigraphy | Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote Ischemic Preconditioning, Partial nephrectomy, Acute kidney injury