Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-24 @ 5:20 PM
Study NCT ID:
NCT01403220
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2011-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.', 'timeFrame': '12 hours', 'description': 'Proportion of dialysis sequences for which the rate of plasma urea reduction \\> 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.'}], 'secondaryOutcomes': [{'measure': 'Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.', 'timeFrame': '24 hours', 'description': 'Proportion of dialysis sequences for which the rate of plasma urea reduction \\> 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.'}, {'measure': 'Urea clearance (ml/min) for the dialysis sequence under study', 'timeFrame': '12 hours', 'description': 'Urea clearance (ml/min) for the dialysis sequence under study.'}, {'measure': 'Filter lifespan (hours) for the dialysis sequence under study.', 'timeFrame': '12 hours.', 'description': 'Filter lifespan (hours) for the dialysis sequence under study.'}, {'measure': 'The percentage down-time for the first 24 hours of dialysis', 'timeFrame': '24 hours', 'description': 'The percentage down-time for the first 24 hours of dialysis = (number of hours where the exchange is not effective / 24 hours)\\*100'}, {'measure': 'Fluid replacement (yes/no)', 'timeFrame': '12 hours', 'description': 'Was fluid replacement necessary during the studied dialysis sequence?'}, {'measure': 'Fluid replacement (yes/no)', 'timeFrame': '24 hours', 'description': 'Was fluid replacement necessary during the studied dialysis sequence?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Failure, Acute']}, 'referencesModule': {'references': [{'pmid': '26538503', 'type': 'RESULT', 'citation': 'Roger C, Muller L, Wallis SC, Louart B, Saissi G, Lipman J, Lefrant JY, Roberts JA. Population pharmacokinetics of linezolid in critically ill patients on renal replacement therapy: comparison of equal doses in continuous venovenous haemofiltration and continuous venovenous haemodiafiltration. J Antimicrob Chemother. 2016 Feb;71(2):464-70. doi: 10.1093/jac/dkv349. Epub 2015 Nov 3.'}, {'pmid': '28035589', 'type': 'DERIVED', 'citation': 'Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Bruggemann RJ, Lefrant JY, Roberts JA. Caspofungin Population Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-Venous Haemofiltration or Haemodiafiltration. Clin Pharmacokinet. 2017 Sep;56(9):1057-1068. doi: 10.1007/s40262-016-0495-z.'}, {'pmid': '27270279', 'type': 'DERIVED', 'citation': 'Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Lefrant JY, Roberts JA. Influence of Renal Replacement Modalities on Amikacin Population Pharmacokinetics in Critically Ill Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4901-9. doi: 10.1128/AAC.00828-16. Print 2016 Aug.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* According to RIFLE score, patient is stage 'F'\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient meets at least one of the following criteria:\n* metabolic acidosis (pH \\< 7.2), excluding keto-acidosis\n* plasma urea \\> 25 mmol/l\n* hyper-hydration is not controlled by diuretics\n\nExclusion Criteria:\n\n* Chronic, terminal renal insufficiency with dialysis\n* The patient is under judicial protection, under tutorship or curatorship\n* Suspect hyperkaliemia (Kaliemia \\> 6.5 mmol/l with electrocardiographic effects)\n* Intoxications treated via dialysis\n* Pregnant, lactating, parturient women\n* Medical indication for localized citrate anticoagulation\n* dialysis of less than 12 h\n* patient or representative refuses to participate"}, 'identificationModule': {'nctId': 'NCT01403220', 'briefTitle': 'The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study', 'orgStudyIdInfo': {'id': 'LOCAL/2011/PJ-02'}, 'secondaryIdInfos': [{'id': '2011-A01550-41', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 (hemodiafiltration first)', 'description': 'This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.', 'interventionNames': ['Procedure: Hemodiafiltration first']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (hemofiltration first)', 'description': 'This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.', 'interventionNames': ['Procedure: Hemofiltration first']}], 'interventions': [{'name': 'Hemodiafiltration first', 'type': 'PROCEDURE', 'description': 'Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.', 'armGroupLabels': ['Group 1 (hemodiafiltration first)']}, {'name': 'Hemofiltration first', 'type': 'PROCEDURE', 'description': 'Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.', 'armGroupLabels': ['Group 2 (hemofiltration first)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Pascal Jeannes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}