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Clinical Trials/NCT03273751
NCT03273751
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country86 target enrollmentSeptember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Neoplasm
Sponsor
Seoul National University Hospital
Enrollment
86
Locations
1
Primary Endpoint
Serum creatinine level
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
August 28, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Won Ho Kim, MD

Clinical Associate Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Serum creatinine level

Time Frame: Postoperative day 1

Postoperative serum creatinine levels as an index of kidney damage

Secondary Outcomes

  • The incidence of acute kidney injury (AKI)(Within 7 days after surgery)
  • estimated glomerular filtration rate (eGFR)(2 weeks after surgery)
  • Urine beta-2 microglobulin(2 weeks after surgery)
  • Serum creatinine level(2 weeks after surgery)
  • Urine microalbumin(2 weeks after surgery)
  • Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side(90 minutes after induction of anesthesia)
  • Urine creatinine level(2 weeks after surgery)
  • Urine N-acetyl-beta-D-glucosaminidase(2 weeks after surgery)
  • Glomerular filtration rate measured by scintigraphy(12 months after surgery)

Study Sites (1)

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