Clinical trial NCT03273751: The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy
Official title: The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Neoplasm
Renal Injury
Keywords: Remote Ischemic Preconditioning
Partial nephrectomy
Acute kidney injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, parallel group, controlled study
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Serum creatinine level
timeFrame: Postoperative day 1
Secondary outcomes:
measure: The incidence of acute kidney injury (AKI)
timeFrame: Within 7 days after surgery
measure: Serum creatinine level
timeFrame: 1 hour after surgery
measure: Serum creatinine level
timeFrame: Postoperative day 3
measure: Serum creatinine level
timeFrame: 2 weeks after surgery
measure: estimated glomerular filtration rate (eGFR)
timeFrame: 1 hour after surgery
measure: estimated glomerular filtration rate (eGFR)
timeFrame: Postoperative day 1
measure: estimated glomerular filtration rate (eGFR)
timeFrame: Postoperative day 3
measure: estimated glomerular filtration rate (eGFR)
timeFrame: 2 weeks after surgery
measure: Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
timeFrame: 5 min after the induction of anesthesia (baseline)
measure: Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
timeFrame: 30 minutes after induction of anesthesia
measure: Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
timeFrame: 60 minutes after induction of anesthesia
measure: Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
timeFrame: 90 minutes after induction of anesthesia
measure: Urine creatinine level
timeFrame: Postoperative day 1
measure: Urine creatinine level
timeFrame: 2 weeks after surgery
measure: Urine microalbumin
timeFrame: Postoperative day 1
measure: Urine microalbumin
timeFrame: 2 weeks after surgery
measure: Urine beta-2 microglobulin
timeFrame: Postoperative day 1
measure: Urine beta-2 microglobulin
timeFrame: 2 weeks after surgery
measure: Urine N-acetyl-beta-D-glucosaminidase
timeFrame: Postoperative day 1
measure: Urine N-acetyl-beta-D-glucosaminidase
timeFrame: 2 weeks after surgery
measure: Glomerular filtration rate measured by scintigraphy
timeFrame: preoperative baseline
measure: Glomerular filtration rate measured by scintigraphy
timeFrame: 6 months after surgery
measure: Glomerular filtration rate measured by scintigraphy
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Won Ho Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.