Renal Injury, Renal Neoplasm
Conditions
Keywords
Remote Ischemic Preconditioning, Partial nephrectomy, Acute kidney injury
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.
Interventions
PROCEDURERemote 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.
PROCEDURESham 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care providers, investigators and outcome assessors will be blinded to group allocation.
Intervention model description
A prospective, randomized, parallel group, controlled study
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine level | Postoperative day 1 | Postoperative serum creatinine levels as an index of kidney damage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine level | 1 hour after surgery | Postoperative serum creatinine levels as an index of kidney damage |
| estimated glomerular filtration rate (eGFR) | 1 hour after surgery | eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD). |
| Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side | 5 min after the induction of anesthesia (baseline) | Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy. |
| Urine creatinine level | Postoperative day 1 | Urine creatinine level |
| 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 |
| Urine beta-2 microglobulin | Postoperative day 1 | Urine beta-2 microglobulin |
| Urine N-acetyl-beta-D-glucosaminidase | Postoperative day 1 | Urine N-acetyl-beta-D-glucosaminidase |
| Glomerular filtration rate measured by scintigraphy | preoperative baseline | Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy |
| Urine microalbumin | Postoperative day 1 | Urine microalbumin |
Countries
South Korea
Outcome results
None listed