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

Seoul National University Hospital86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Renal Neoplasm Renal Injury

Interventions

Remote Ischemic PreconditioningPROCEDURE

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 controlPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Serum creatinine level

Postoperative serum creatinine levels as an index of kidney damage

Time frame: Postoperative day 1

Secondary Outcomes

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

Time frame: Within 7 days after surgery

Serum creatinine level

Postoperative serum creatinine levels as an index of kidney damage

Time frame: 1 hour after surgery

Serum creatinine level

Postoperative serum creatinine levels as an index of kidney damage

Time frame: Postoperative day 3

Serum creatinine level

Postoperative serum creatinine levels as an index of kidney damage

Time frame: 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).

Time frame: 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).

Time frame: Postoperative day 1

estimated glomerular filtration rate (eGFR)

Data from ClinicalTrials.gov

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