Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT02050269
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2014-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007472', 'term': 'Iohexol'}], 'ancestors': [{'id': 'D014283', 'term': 'Triiodobenzoic Acids'}, {'id': 'D007463', 'term': 'Iodobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma clearance of iohexol', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Plasma clearance of iohexol in patients developping or not acute kidney injury', 'timeFrame': '7 days'}, {'measure': 'Link between plasma iohexol clearance and kindney injury markers', 'timeFrame': '24 hours'}, {'measure': 'Link between injury and/or functional kidney dammage and subsequent acute kidney injury', 'timeFrame': '7 days'}, {'measure': 'Link between plasma iohexol clearance and urinary metabolomic markers', 'timeFrame': '24 hours'}, {'measure': 'Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Circulatory Failure']}, 'referencesModule': {'references': [{'pmid': '27166722', 'type': 'RESULT', 'citation': 'Salmon-Gandonniere C, Benz-de Bretagne I, Mercier E, Joret A, Halimi JM, Ehrmann S, Barin-Le Guellec C. Iohexol clearance in unstable critically ill patients: a tool to assess glomerular filtration rate. Clin Chem Lab Med. 2016 Nov 1;54(11):1777-1786. doi: 10.1515/cclm-2015-1202.'}, {'pmid': '33710029', 'type': 'DERIVED', 'citation': 'Desgrouas M, Merdji H, Bretagnol A, Barin-Le Guellec C, Halimi JM, Ehrmann S, Salmon Gandonniere C. Kinetic Glomerular Filtration Rate Equations in Patients With Shock: Comparison With the Iohexol-Based Gold-Standard Method. Crit Care Med. 2021 Aug 1;49(8):e761-e770. doi: 10.1097/CCM.0000000000004946.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the feasibility of estimating the clearance of iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal function in the intensive care unit through analysis of rich iohexol plasma kinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient admitted to intensive care for less than 12 hours\n* Acute circulatory failure\n* Patient carrying an arterial catheter\n* Informed consent obtained\n* Affiliated to social security system\n\nExclusion Criteria:\n\n* Administration of iohexol the week before intensive care admission\n* Administration of iohexol expected within 24 hours of study entry\n* Known history of cutaneous immediate or delayed allergic reaction to the injection of the product\n* Indication for albumin transfusion within 24 hours of potential inclusion in the study\n* Pregnancy or breastfeeding in progress\n* Patient under guardianship or judicial protection known at the time of inclusion\n* Withdrawal of consent\n* Administration of iohexol outside the study within 24 hours after administration of iohexol in the context of the study\n* Administration of intravenous albumin in the 24 hours following administration of iohexol in the context of the study'}, 'identificationModule': {'nctId': 'NCT02050269', 'acronym': 'IoxRea', 'briefTitle': 'Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study', 'orgStudyIdInfo': {'id': 'PHAO13-SE / IoxRea'}, 'secondaryIdInfos': [{'id': '2013-003936-65', 'type': 'EUDRACT_NUMBER'}, {'id': '2013-R49', 'type': 'OTHER', 'domain': 'CPP'}, {'id': '131229A-11', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iohexol', 'description': 'injection of 5 ml of iohexol', 'interventionNames': ['Drug: Iohexol']}], 'interventions': [{'name': 'Iohexol', 'type': 'DRUG', 'description': 'Iohexol, 300 mg/mL', 'armGroupLabels': ['Iohexol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45000', 'city': 'Orléans', 'country': 'France', 'facility': 'Hospital La SOURCE', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'University Hospital Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Service de Réanimation Polyvalente, CHRU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Stephan EHRMANN, MCU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}