Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT03273751
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2017-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, care providers, investigators and outcome assessors will be blinded to group allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, randomized, parallel group, controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2017-09-03', 'studyFirstSubmitQcDate': '2017-09-03', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum creatinine level', 'timeFrame': 'Postoperative day 1', 'description': 'Postoperative serum creatinine levels as an index of kidney damage'}], 'secondaryOutcomes': [{'measure': 'The incidence of acute kidney injury (AKI)', 'timeFrame': 'Within 7 days after surgery', 'description': 'The incidence of AKI according to the serum creatinine diagnostic criteria of Kidney Disease Improving Global outcomes (KDIGO) Clinical Practice Guideline for AKI'}, {'measure': 'Serum creatinine level', 'timeFrame': '1 hour after surgery', 'description': 'Postoperative serum creatinine levels as an index of kidney damage'}, {'measure': 'Serum creatinine level', 'timeFrame': 'Postoperative day 3', 'description': 'Postoperative serum creatinine levels as an index of kidney damage'}, {'measure': 'Serum creatinine level', 'timeFrame': '2 weeks after surgery', 'description': 'Postoperative serum creatinine levels as an index of kidney damage'}, {'measure': 'estimated glomerular filtration rate (eGFR)', 'timeFrame': '1 hour after surgery', 'description': 'eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).'}, {'measure': 'estimated glomerular filtration rate (eGFR)', 'timeFrame': 'Postoperative day 1', 'description': 'eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).'}, {'measure': 'estimated glomerular filtration rate (eGFR)', 'timeFrame': 'Postoperative day 3', 'description': 'eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).'}, {'measure': 'estimated glomerular filtration rate (eGFR)', 'timeFrame': '2 weeks after surgery', 'description': 'eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).'}, {'measure': 'Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side', 'timeFrame': '5 min after the induction of anesthesia (baseline)', 'description': 'Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.'}, {'measure': 'Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side', 'timeFrame': '30 minutes after induction of anesthesia', 'description': 'Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.'}, {'measure': 'Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side', 'timeFrame': '60 minutes after induction of anesthesia', 'description': 'Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.'}, {'measure': 'Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side', 'timeFrame': '90 minutes after induction of anesthesia', 'description': 'Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.'}, {'measure': 'Urine creatinine level', 'timeFrame': 'Postoperative day 1', 'description': 'Urine creatinine level'}, {'measure': 'Urine creatinine level', 'timeFrame': '2 weeks after surgery', 'description': 'Urine creatinine level'}, {'measure': 'Urine microalbumin', 'timeFrame': 'Postoperative day 1', 'description': 'Urine microalbumin'}, {'measure': 'Urine microalbumin', 'timeFrame': '2 weeks after surgery', 'description': 'Urine microalbumin'}, {'measure': 'Urine beta-2 microglobulin', 'timeFrame': 'Postoperative day 1', 'description': 'Urine beta-2 microglobulin'}, {'measure': 'Urine beta-2 microglobulin', 'timeFrame': '2 weeks after surgery', 'description': 'Urine beta-2 microglobulin'}, {'measure': 'Urine N-acetyl-beta-D-glucosaminidase', 'timeFrame': 'Postoperative day 1', 'description': 'Urine N-acetyl-beta-D-glucosaminidase'}, {'measure': 'Urine N-acetyl-beta-D-glucosaminidase', 'timeFrame': '2 weeks after surgery', 'description': 'Urine N-acetyl-beta-D-glucosaminidase'}, {'measure': 'Glomerular filtration rate measured by scintigraphy', 'timeFrame': 'preoperative baseline', 'description': 'Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy'}, {'measure': 'Glomerular filtration rate measured by scintigraphy', 'timeFrame': '6 months after surgery', 'description': 'Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy'}, {'measure': 'Glomerular filtration rate measured by scintigraphy', 'timeFrame': '12 months after surgery', 'description': 'Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remote Ischemic Preconditioning', 'Partial nephrectomy', 'Acute kidney injury'], 'conditions': ['Renal Neoplasm', 'Renal Injury']}, 'referencesModule': {'references': [{'pmid': '23452148', 'type': 'BACKGROUND', '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."}, {'pmid': '26024502', 'type': 'BACKGROUND', '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.'}, {'pmid': '26936039', 'type': 'BACKGROUND', '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.'}, {'pmid': '30180887', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients scheduled to undergo open, laparoscopic, or robot-assisted laparoscopic partial nephrectomy\n* Normal contralateral renal function was defined as split renal function of \\>40% as determined by preoperative Tc-99m DiethyleneTriamine Pentaacetic Acid (DTPA) kidney scan\n* Written informed consent\n\nExclusion Criteria:\n\n* Peripheral vascular disease involving upper extremities or lower extremities\n* Severe cardiopulmonary diseases (valvular or ischemic heart disease, heart failure, chronic obstructive pulmonary disease)\n* Hepatic failure, renal failure'}, 'identificationModule': {'nctId': 'NCT03273751', 'briefTitle': 'The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1707-087-870'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote Ischemic Preconditioning (RIPC)', 'description': 'Four cycles of upper arm ischemia/reperfusion', 'interventionNames': ['Procedure: Remote Ischemic Preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham control', 'description': 'Placement of a blood pressure cuff around upper arm without inflation.', 'interventionNames': ['Procedure: Sham control']}], 'interventions': [{'name': 'Remote Ischemic Preconditioning', 'type': 'PROCEDURE', 'otherNames': ['RIPC'], '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.', 'armGroupLabels': ['Remote Ischemic Preconditioning (RIPC)']}, {'name': 'Sham control', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Sham control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Won Ho Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Won Ho Kim, MD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}