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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Neoplasm; Renal Injury
• Intervention / Treatment: Procedure: Remote Ischemic Preconditioning; Procedure: Sham control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Won Ho Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): August 28, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: September 3, 2017
• First Submitted That Met QC Criteria: September 3, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Partial nephrectomy; Acute kidney injury; Remote Ischemic Preconditioning
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: 1707-087-870

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No