Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT00537693
Status:
COMPLETED
Last Update Posted:
2010-09-02
First Post:
2007-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytokine Removal by CRRT in Pediatric Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079664', 'term': 'Continuous Renal Replacement Therapy'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-01', 'studyFirstSubmitDate': '2007-09-27', 'studyFirstSubmitQcDate': '2007-09-27', 'lastUpdatePostDateStruct': {'date': '2010-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A 25% additional decrease in IL-6 concentration change', 'timeFrame': 'The First 24 hours of CRRT'}], 'secondaryOutcomes': [{'measure': 'Other cytokine removal rates', 'timeFrame': 'First 24 hours of CRRT'}, {'measure': 'Cytokine absorption on the CRRT membrane', 'timeFrame': 'First 24 hours of CRRT'}, {'measure': 'Hemodynamic parameters', 'timeFrame': 'First 24 hours of CRRT'}, {'measure': 'Changes in serum cytokine concentrations and clearance', 'timeFrame': 'After crossover, from 24-48 hours'}, {'measure': 'Changes in serum cytokine concentrations', 'timeFrame': 'From beginning to end of the study, independent of modality'}]}, 'conditionsModule': {'keywords': ['Continuous Renal Replacement Therapy (CRRT)', 'Sepsis', 'Convection', 'Diffusion'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'This pilot study will compare the effect of diffusive versus convective Continuous Renal Replacement Therapy (CRRT) in children with sepsis who require CRRT.\n\nThe hypothesis for the study is that convective forms of CRRT provide enhanced clearance of cytokines and improved clinical responses as compared to a diffusive CRRT modality.', 'detailedDescription': 'The purpose of this study is to test the hypothesis that convective forms of Continuous Renal Replacement Therapy (CRRT) provides enhanced clearance of cytokines compared to a diffusive CRRT modality. Also, we plan to test the hypothesis that patients who receive convective CRRT modalities demonstrate improved clinical responses to patients who receive a diffusive CRRT modality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with documented sepsis or suspected SIRS\n* Patients initiating CRRT\n* Age 1 to 21 years\n\nExclusion Criteria:\n\n* Patients on ECMO\n* Patients receiving concomitant plasma exchange\n* Cardiopulmonary bypass procedure within 96 hours of CRRT\n* Patients with new onset acute leukemia\n* Patients with active autoimmune disease\n* Ungrafted stem cell transplant recipients'}, 'identificationModule': {'nctId': 'NCT00537693', 'briefTitle': 'Cytokine Removal by CRRT in Pediatric Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion', 'orgStudyIdInfo': {'id': 'H-21133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'CRRT via Convection', 'interventionNames': ['Procedure: Continuous Renal Replacement Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'CRRT via Diffusion', 'interventionNames': ['Procedure: Continuous Renal Replacement Therapy']}], 'interventions': [{'name': 'Continuous Renal Replacement Therapy', 'type': 'PROCEDURE', 'description': 'Patients will be randomized to either arm for the first 24 hours of the study and then crossover to the second arm for the second 24 hours of the study.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Helen De Vos Children's Hospital", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Childrens Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Stuart Goldstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dialysis Solutions Inc.', 'class': 'INDUSTRY'}]}}}