Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-25 @ 12:23 AM
Study NCT ID:
NCT02962700
Status:
UNKNOWN
Last Update Posted:
2016-11-11
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in the concentration of glucose (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle.', 'timeFrame': 'at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement'}, {'measure': 'changes in the concentration of lactate (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle', 'timeFrame': 'at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement'}, {'measure': 'changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle', 'timeFrame': 'at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement'}, {'measure': 'changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle', 'timeFrame': 'at baseline, 6, 12,18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement'}], 'secondaryOutcomes': [{'measure': 'changes in mean arterial blood pressure', 'timeFrame': 'at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement'}, {'measure': 'changes in heart rate', 'timeFrame': 'at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement'}, {'measure': 'changes in vasopressor support doses', 'timeFrame': 'at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['continuous haemofiltration', 'intermittent haemodialysis'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to investigate whether CVVH, in comparison to intermittent haemodialysis (IHD), is able to improve regional perfusion in septic shock patients studied by muscle microdialysis', 'detailedDescription': 'A prospective, randomized, clinical study ,including septic shock patients with acute renal failure, aged over 16 years. Patients were randomized to receive either CVVH or IHD for renal replacement therapy. Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period. Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* septic shock\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02962700', 'briefTitle': 'Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Military Hospital of Tunis'}, 'officialTitle': 'Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock', 'orgStudyIdInfo': {'id': 'CVVHFmicro'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVVHF', 'description': 'CVVHF for 48 h interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.', 'interventionNames': ['Device: muscle microdialysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IHD for 4 hours', 'description': 'Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period.\n\nInterstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.', 'interventionNames': ['Device: muscle microdialysis']}], 'interventions': [{'name': 'muscle microdialysis', 'type': 'DEVICE', 'description': 'Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.', 'armGroupLabels': ['CVVHF', 'IHD for 4 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1008', 'city': 'Tunis', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'mustapha ferjani', 'role': 'CONTACT', 'email': 'mustapha.ferjani@planet.tn', 'phone': '98329256'}, {'name': 'zied hajjej', 'role': 'CONTACT', 'email': 'hajjej_zied@hotmail.com', 'phone': '20358907'}], 'facility': 'Military Hopital of Tunis', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'zied hajjej', 'role': 'CONTACT', 'email': 'hajjej_zied@hotmail.com', 'phone': '20358907', 'phoneExt': '00216'}, {'name': 'mustapha ferjani', 'role': 'CONTACT', 'email': 'mustapha.ferjani@planet.tn', 'phone': '98329256', 'phoneExt': '00216'}], 'overallOfficials': [{'name': 'mustapha ferhjani', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Hospital of Tunis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Hajjej Zied', 'investigatorAffiliation': 'Military Hospital of Tunis'}}}}