Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-31 @ 5:36 AM
Study NCT ID:
NCT03014232
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2017-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Cytokine Clearance Between SLED-f Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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': '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2017-01-04', 'studyFirstSubmitQcDate': '2017-01-05', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-6 Clearance', 'timeFrame': 'At 30 minutes after the treatment was started', 'description': 'Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.'}], 'secondaryOutcomes': [{'measure': 'Urea percentage of reduction ratio', 'timeFrame': 'At time 0-hour and 6-hour of the study SLED-f session', 'description': 'Blood samples were taken from patients before and at the end of 6-hour in the first online SLED-f session. The percentage of reduction ratio were calculated from the before and ending samples.'}, {'measure': 'Beta2-microglobulin percentage of reduction ratio', 'timeFrame': 'At time 0-hour and 6-hour of the study SLED-f session', 'description': 'Blood samples were taken from patients before and at the end of 6-hour in the first online SLED-f session. The percentage of reduction ratio were calculated from the before and ending samples.'}, {'measure': 'IL-10 Clearances', 'timeFrame': 'At 30 minutes after the treatment was started', 'description': 'Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.'}, {'measure': 'TNF-α Clearances', 'timeFrame': 'At 30 minutes after the treatment was started', 'description': 'Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.'}, {'measure': 'Intradialytic hypotension', 'timeFrame': 'During 6 hours of SLED-f session', 'description': 'The hypotensive events were records'}, {'measure': 'Albumin loss in spent dialysate', 'timeFrame': 'During 6 hours of SLED-f session', 'description': 'Continuous sampling of spent effluent dialysate and ultrafiltrate were carried out with a collection pump inserted into the effluent outlet line via a special connector for total albumin loss determination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sustained low-efficiency diafiltration (SLED-f)', 'high cut-off dialyzer', 'cytokines'], 'conditions': ['Sepsis', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).', 'detailedDescription': 'Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high mortality in sepsis-related acute kidney injury(AKI). Reductions of these cytokines have been reported to improve clinical outcomes. Online sustained low-efficiency diafiltration(SLED-f) using traditional high-flux(HF) dialyzer could remove some cytokines. Interestingly, the potential of enhancing cytokine removal by using newly designed high cut-off(HCO) dialyzer that could theoretically remove larger molecular weight solutes has never been studied in SLED-f before.This pilot randomized controlled trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO dialyzer(HCO-SLED-f,n=8) and HF dialyzer(HF-SLED-f,n=8).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sepsis\n* Acute kidney injury stage 3\n\nExclusion Criteria:\n\n* Profound hemodynamic instability with more than one inotropic drug\n* Pregnancy\n* Breast-feeding\n* Delayed receiving antibiotic up to 6 hours after beginning of septic shock.'}, 'identificationModule': {'nctId': 'NCT03014232', 'briefTitle': 'Comparison Cytokine Clearance Between SLED-f Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Comparison Cytokine Clearance Between Sustained Low-Efficiency Diafiltration (SLED-f) Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients', 'orgStudyIdInfo': {'id': '271/54'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLED-f with HCO dialyzer', 'description': 'Online sustained low-efficiency diafiltration (online SLED-f) using novel high cut-off dialyzer which had larger pore size than standard high-flux dialyzer was assigned as the new intervention to compare the efficacy of cytokine removals with the control arm.', 'interventionNames': ['Procedure: SLED-f with HCO dialyzer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLED-f with HF dialyzer', 'description': 'Online sustained low-efficiency diafiltration (online SLED-f) using standard high-flux dialyzer in septic acute kidney injury patients was assigned as the control group', 'interventionNames': ['Procedure: SLED-f with HF dialyzer']}], 'interventions': [{'name': 'SLED-f with HCO dialyzer', 'type': 'PROCEDURE', 'description': 'Online SLED-f with high cut-off dialyzers were performed using the Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). Super-flux, Sureflux 150FH (Nipro Corporation, Osaka, Japan; cellulose triacetate material, pore size 78 A◦, Kuf 66.9 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).', 'armGroupLabels': ['SLED-f with HCO dialyzer']}, {'name': 'SLED-f with HF dialyzer', 'type': 'PROCEDURE', 'description': 'Online SLED-f with standard high-flux dialyzers were performed using the same Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). High-flux ELISIO 150H (Nipro Corporation, Osaka, Japan; polynephron material, pore size 50-60 A◦, Kuf 67 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).', 'armGroupLabels': ['SLED-f with HF dialyzer']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Khajohn Tiranathanagul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}, {'name': 'Jeeraluk Tunpornchai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Khajohn Tiranathanagul', 'investigatorAffiliation': 'Chulalongkorn University'}}}}