Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-04-20 @ 12:08 PM
Study NCT ID:
NCT02793661
Status:
UNKNOWN
Last Update Posted:
2016-09-05
First Post:
2016-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-02', 'studyFirstSubmitDate': '2016-06-03', 'studyFirstSubmitQcDate': '2016-06-03', 'lastUpdatePostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of contrast-induced nephropathy', 'timeFrame': 'Within 5 days', 'description': 'The occurence of contrast-induced nephropathy will be determined:\n\n* by an elevation, within 3 days from requiring contrast-procedure, of the serum creatinine (rise of 0.3mg/dl or of 25% compared to basal value) and/or\n* by the need for dialysis within 5 fays from requiring contrast-procedure'}], 'secondaryOutcomes': [{'measure': 'Change in serum creatinin value', 'timeFrame': 'at 12 +-1 months'}, {'measure': 'Change in the estimated glomerular filtration rate', 'timeFrame': 'at 12 +-1 months'}, {'measure': 'Percentage of patients on chronic dialysis', 'timeFrame': 'at 12 +-1 months'}, {'measure': 'Percentage of patients on temporary dialysis', 'timeFrame': 'at 12 +-1 months'}, {'measure': 'In hospital significant urinary bleeding, infection or any other major complication cause by the urinary catheter', 'timeFrame': 'within 5 days from procedure'}, {'measure': 'Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)', 'timeFrame': 'at 12 +-1 months'}, {'measure': 'Individual MACCEs components (death, myocardial infarction, stroke, revascularization)', 'timeFrame': 'at 12 +-1 months'}, {'measure': 'Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines', 'timeFrame': 'Index hospitalization (including staged procedures) and 12+- 1 months', 'description': 'cost utility analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiovascular Disease', 'Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '39878152', 'type': 'DERIVED', 'citation': 'Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The Strength study aim to evaluate the use of the RenalGuard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast.', 'detailedDescription': "The Strength Trial is a randomized, international (France and Germany) and multicentre (7) trial.\n\nThe patients population targeted is suffering from kidney insufficiency (estimated Glomerular Filtration Rate (eGFR) between 15 to 40 ml/min/m2) need to go through a complex cardiovascular intervention..\n\nThis is a population of patients at high risk to develop AKI following contrast media administration and complex cardiovascular interventions require a high amount of contrast.\n\nStandard treatment is hydration but with risk of hyper and hypohydration for this population of patients. RenalGuard insure the replacement of the urine output by infusion of a matched volume of sterile replacement solution to maintain patients' intravascular fluid volume.\n\nThe patients are randomized to be protected from contrast-induced nephropathy with the use of RenalGuard or by standard hydration treatment and will be followed-up during 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* 15 ml/min/m2 ≤ eGFR ≤ 40 ml/min/m2\n* High volume contrast-requiring cardiovascular procedures (estimated contrast volume \\> 3 times eGFR value)\n* Patient has agreed to all FU testing\n\nExclusion Criteria:\n\n* Administration of iodine contrast media within 5 days before index procedure\n* Emergency procedure or primary PCI\n* Patients with pulmonary edema or cardiogenic shock (Killip 3 or 4)\n* Hypoxemia defined as SaO2 ≤ 90% and/or PaO2 ≤ 80 mmHg on room air\n* Acute Kidney Injury requiring dialysis before the procedure\n* Multiple myeloma or cancer treated with chemotherapy\n* Subjet is anuric\n* Subject has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month\n* Known hypersensitivity to furosemide active ingredient or excipient\n* Renal insufficiency with oligoanuria resistant to furosemide or caused by nephrotoxic or hepatotoxic substances\n* Pre-coma or coma induced by an hepatic encephalopathy\n* Severe hypokalemia, sever hyponatremia, hypovolemia with or without hypotension or dehydration\n* Hypersensitivity to sulfamides\n* Enrollment in another study unless the study is a registry or unless primary endpoint is reached\n* Expected life expectancy \\< 1 year\n* Pregnant or breastfeeding patient\n* Patient under trusteeship or guardianship\n* Patient is unable / unwilling to provide an informed consent'}, 'identificationModule': {'nctId': 'NCT02793661', 'acronym': 'STRENGTH', 'briefTitle': 'Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI', 'organization': {'class': 'NETWORK', 'fullName': 'European Cardiovascular Research Center'}, 'officialTitle': 'Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH)', 'orgStudyIdInfo': {'id': 'REN-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RenalGuard Arm', 'description': 'In order to prevent patients from acute kidney injury, patients will receive the RenalGuard Therapy delivered by the RenalGuard system from one hour before the cardiovascular intervention to 4 hours after the intervention.', 'interventionNames': ['Device: RenalGuard']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'Patient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'RenalGuard', 'type': 'DEVICE', 'description': "Replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient's intravascular fluid volume. Diuretic is administered to reach an optimum urine flow and protect efficiently the patients' kidneys.", 'armGroupLabels': ['RenalGuard Arm']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Hydration protocol following ESC Guidelines 2014', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91300', 'city': 'Massy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Garot', 'role': 'CONTACT', 'email': 'pgarot@angio-icps.com', 'phone': '+33160134602'}, {'name': 'Philippe Garot', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Privé Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '91480', 'city': 'Quincy-sous-Sénart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Garot', 'role': 'CONTACT', 'email': 'pgarot@angio-icps.com', 'phone': '+33169399169'}, {'name': 'Philippe Garot', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Privé Claude Galien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Didier Carrié', 'role': 'CONTACT', 'email': 'carrie.didier@chu-toulouse.fr'}, {'name': 'Didier Carrié', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31076', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Fajadet', 'role': 'CONTACT', 'email': 'jfajadet@clinique-pasteur.com'}, {'name': 'Jean Fajadet', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '53105', 'city': 'Bonn', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georg Nickenig', 'role': 'CONTACT', 'email': 'georg.nickenig@ukb.uni-bonn.de'}, {'name': 'Georg Nickenig', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '60389', 'city': 'Frankfurt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Horst Sievert', 'role': 'CONTACT', 'email': 'horstsievertmd@aol.com'}, {'name': 'Horst Sievert', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiovasculares Centrum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '65189', 'city': 'Wiesbaden', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Horst Sievert, Prof', 'role': 'CONTACT', 'email': 'horstsievertmd@aol.com'}, {'name': 'Horst Sievert, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St Josefs Hospital', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'centralContacts': [{'name': 'Jessica Heringer, PhD', 'role': 'CONTACT', 'email': 'jheringer@cerc-europe.org', 'phone': '+33 (0)1 76 73 92 16'}, {'name': 'Laure Morsiani, Ph D', 'role': 'CONTACT', 'email': 'lmorsiani@cerc-europe.org', 'phone': '+33 (0)1 76 73 92 36'}], 'overallOfficials': [{'name': 'Andrew Halpert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RenalGuard Solutions, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Cardiovascular Research Center', 'class': 'NETWORK'}, 'collaborators': [{'name': 'RenalGuard Solutions, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}