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

Not Applicable

Completed

• Conditions: Renal Neoplasm; Renal Injury
• Interventions: Procedure: Remote Ischemic Preconditioning; Procedure: Sham control

• Registration Number: NCT03273751
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-03
• Study First Submitted QC: 2017-09-03
• Study First Posted: 2017-09-06
• Primary Completion: 2018-08-28
• Study Completion: 2018-08-28
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Preconditioning (RIPC)	Remote Ischemic Preconditioning	Four cycles of upper arm ischemia/reperfusion
Sham control	Sham control	Placement of a blood pressure cuff around upper arm without inflation.

Primary Outcome Measures

Name	Time	Method
Serum creatinine level	Postoperative day 1	Postoperative serum creatinine levels as an index of kidney damage

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of