The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy
Primary Purpose
Renal Neoplasm, Renal Injury
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
Sham control
Sponsored by
About this trial
This is an interventional prevention trial for Renal Neoplasm focused on measuring Remote Ischemic Preconditioning, Partial nephrectomy, Acute kidney injury
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Remote Ischemic Preconditioning (RIPC)
Sham control
Arm Description
Four cycles of upper arm ischemia/reperfusion
Placement of a blood pressure cuff around upper arm without inflation.
Outcomes
Primary Outcome Measures
Serum creatinine level
Postoperative serum creatinine levels as an index of kidney damage
Secondary Outcome Measures
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
Serum creatinine level
Postoperative serum creatinine levels as an index of kidney damage
Serum creatinine level
Postoperative serum creatinine levels as an index of kidney damage
Serum creatinine level
Postoperative serum creatinine levels as an index of kidney damage
estimated glomerular filtration rate (eGFR)
eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
estimated glomerular filtration rate (eGFR)
eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
estimated glomerular filtration rate (eGFR)
eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
estimated glomerular filtration rate (eGFR)
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
Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.
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.
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.
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.
Urine creatinine level
Urine creatinine level
Urine creatinine level
Urine creatinine level
Urine microalbumin
Urine microalbumin
Urine microalbumin
Urine microalbumin
Urine beta-2 microglobulin
Urine beta-2 microglobulin
Urine beta-2 microglobulin
Urine beta-2 microglobulin
Urine N-acetyl-beta-D-glucosaminidase
Urine N-acetyl-beta-D-glucosaminidase
Urine N-acetyl-beta-D-glucosaminidase
Urine N-acetyl-beta-D-glucosaminidase
Glomerular filtration rate measured by scintigraphy
Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy
Glomerular filtration rate measured by scintigraphy
Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy
Glomerular filtration rate measured by scintigraphy
Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy
Full Information
NCT ID
NCT03273751
First Posted
September 3, 2017
Last Updated
October 20, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03273751
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Neoplasm, Renal Injury
Keywords
Remote Ischemic Preconditioning, Partial nephrectomy, Acute kidney injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized, parallel group, controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants, care providers, investigators and outcome assessors will be blinded to group allocation.
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Ischemic Preconditioning (RIPC)
Arm Type
Experimental
Arm Description
Four cycles of upper arm ischemia/reperfusion
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
Placement of a blood pressure cuff around upper arm without inflation.
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning
Other Intervention Name(s)
RIPC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum creatinine level
Description
Postoperative serum creatinine levels as an index of kidney damage
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
The incidence of acute kidney injury (AKI)
Description
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
Title
Serum creatinine level
Description
Postoperative serum creatinine levels as an index of kidney damage
Time Frame
1 hour after surgery
Title
Serum creatinine level
Description
Postoperative serum creatinine levels as an index of kidney damage
Time Frame
Postoperative day 3
Title
Serum creatinine level
Description
Postoperative serum creatinine levels as an index of kidney damage
Time Frame
2 weeks after surgery
Title
estimated glomerular filtration rate (eGFR)
Description
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
Title
estimated glomerular filtration rate (eGFR)
Description
eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
Time Frame
Postoperative day 1
Title
estimated glomerular filtration rate (eGFR)
Description
eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
Time Frame
Postoperative day 3
Title
estimated glomerular filtration rate (eGFR)
Description
eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).
Time Frame
2 weeks after surgery
Title
Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
Description
Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.
Time Frame
5 min after the induction of anesthesia (baseline)
Title
Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
Description
Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.
Time Frame
30 minutes after induction of anesthesia
Title
Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
Description
Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.
Time Frame
60 minutes after induction of anesthesia
Title
Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side
Description
Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.
Time Frame
90 minutes after induction of anesthesia
Title
Urine creatinine level
Description
Urine creatinine level
Time Frame
Postoperative day 1
Title
Urine creatinine level
Description
Urine creatinine level
Time Frame
2 weeks after surgery
Title
Urine microalbumin
Description
Urine microalbumin
Time Frame
Postoperative day 1
Title
Urine microalbumin
Description
Urine microalbumin
Time Frame
2 weeks after surgery
Title
Urine beta-2 microglobulin
Description
Urine beta-2 microglobulin
Time Frame
Postoperative day 1
Title
Urine beta-2 microglobulin
Description
Urine beta-2 microglobulin
Time Frame
2 weeks after surgery
Title
Urine N-acetyl-beta-D-glucosaminidase
Description
Urine N-acetyl-beta-D-glucosaminidase
Time Frame
Postoperative day 1
Title
Urine N-acetyl-beta-D-glucosaminidase
Description
Urine N-acetyl-beta-D-glucosaminidase
Time Frame
2 weeks after surgery
Title
Glomerular filtration rate measured by scintigraphy
Description
Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy
Time Frame
preoperative baseline
Title
Glomerular filtration rate measured by scintigraphy
Description
Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy
Time Frame
6 months after surgery
Title
Glomerular filtration rate measured by scintigraphy
Description
Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Ho Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23452148
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.
Results Reference
background
PubMed Identifier
26024502
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.
Results Reference
background
PubMed Identifier
26936039
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.
Results Reference
background
PubMed Identifier
30180887
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.
Results Reference
derived
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The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy
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