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

Renal Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273751
• Other study ID #: 1707-087-870
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: August 28, 2018

Study information

• Verified date: October 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Injury
• Renal Neoplasm

Intervention

Procedure:
• Remote 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.
• Sham 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Görlich 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine level	Postoperative serum creatinine levels as an index of kidney damage	Postoperative day 1
Secondary	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	Within 7 days after surgery
Secondary	Serum creatinine level	Postoperative serum creatinine levels as an index of kidney damage	1 hour after surgery
Secondary	Serum creatinine level	Postoperative serum creatinine levels as an index of kidney damage	Postoperative day 3
Secondary	Serum creatinine level	Postoperative serum creatinine levels as an index of kidney damage	2 weeks after surgery
Secondary	estimated glomerular filtration rate (eGFR)	eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).	1 hour after surgery
Secondary	estimated glomerular filtration rate (eGFR)	eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).	Postoperative day 1
Secondary	estimated glomerular filtration rate (eGFR)	eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).	Postoperative day 3
Secondary	estimated glomerular filtration rate (eGFR)	eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).	2 weeks after surgery
Secondary	Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side	Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.	5 min after the induction of anesthesia (baseline)
Secondary	Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side	Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.	30 minutes after induction of anesthesia
Secondary	Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side	Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.	60 minutes after induction of anesthesia
Secondary	Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side	Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.	90 minutes after induction of anesthesia
Secondary	Urine creatinine level	Urine creatinine level	Postoperative day 1
Secondary	Urine creatinine level	Urine creatinine level	2 weeks after surgery
Secondary	Urine microalbumin	Urine microalbumin	Postoperative day 1
Secondary	Urine microalbumin	Urine microalbumin	2 weeks after surgery
Secondary	Urine beta-2 microglobulin	Urine beta-2 microglobulin	Postoperative day 1
Secondary	Urine beta-2 microglobulin	Urine beta-2 microglobulin	2 weeks after surgery
Secondary	Urine N-acetyl-beta-D-glucosaminidase	Urine N-acetyl-beta-D-glucosaminidase	Postoperative day 1
Secondary	Urine N-acetyl-beta-D-glucosaminidase	Urine N-acetyl-beta-D-glucosaminidase	2 weeks after surgery
Secondary	Glomerular filtration rate measured by scintigraphy	Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy	preoperative baseline
Secondary	Glomerular filtration rate measured by scintigraphy	Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy	6 months after surgery
Secondary	Glomerular filtration rate measured by scintigraphy	Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy	12 months after surgery