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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic Preconditioning (RIPC) | Experimental | Four cycles of upper arm ischemia/reperfusion |
|
| Sham control | Sham Comparator | Placement of a blood pressure cuff around upper arm without inflation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic Preconditioning | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine level | Postoperative serum creatinine levels as an index of kidney damage | Postoperative day 1 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Ho Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23452148 | Background | 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. | |
| 26024502 | Background |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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A prospective, randomized, parallel group, controlled study
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Participants, care providers, investigators and outcome assessors will be blinded to group allocation.
|
|
| Sham control | 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. |
|
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 |
| 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. |
| 26936039 | Background | 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. |
| 30180887 | Derived | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |