Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-11 @ 8:03 PM
Study NCT ID:
NCT00837057
Status:
UNKNOWN
Last Update Posted:
2009-02-05
First Post:
2009-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'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': 'D012769', 'term': 'Shock'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079664', 'term': 'Continuous Renal Replacement Therapy'}, {'id': 'D017582', 'term': 'Renal Replacement Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'lastUpdateSubmitDate': '2009-02-04', 'studyFirstSubmitDate': '2009-02-04', 'studyFirstSubmitQcDate': '2009-02-04', 'lastUpdatePostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death from all causes at 28 days after randomisation', 'timeFrame': '28 day'}], 'secondaryOutcomes': [{'measure': 'Death within the in the intensive care unit. Death within 90 days of randomisation. Death prior to hospital discharge. Length of ICU stay. The need for and duration of other organ support', 'timeFrame': '90 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Sepsis', 'Septic Shock', 'Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '36416787', 'type': 'DERIVED', 'citation': 'Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Severe sepsis or septic shock with acute kidney injury shows high mortality in intensive care unit. A few studies have shown CRRT relating the clinical improvement seems to be related to the early initiation of therapy. But there is no consensus for proper time of CRRT may improve the prognosis.\n\nThe study is a prospective randomized one center trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU, treated either early by CRRT (35 ml/kg/h) or by conventional RRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Septic shock (Bone criteria) for less than 14D\n* RIFLE criteria : Injury or Failure or nearly anuria more than 2hr\n* Age over 18 years\n* Written informed consent by next of kin.\n\nExclusion Criteria:\n\n* Cirrhosis child class C\n* CRF or ESRD\n* Too high APACHE II \\& SOFA score at admission\n* Age over 80 years\n* Life expectancy less than 3 months (metastatic cancer - hepatoma, lung ca.)'}, 'identificationModule': {'nctId': 'NCT00837057', 'briefTitle': 'Early Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Randomized Controlled Multi-Center Trial of the Early Application of CRRT in Patients With Severe Sepsis or Septic Shock', 'orgStudyIdInfo': {'id': 'a085068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'early crrt, late crrt', 'interventionNames': ['Procedure: crrt']}], 'interventions': [{'name': 'crrt', 'type': 'PROCEDURE', 'otherNames': ['renal replacement therapy, timing'], 'description': 'early CRRT (35 ml/kg/h)\\& acute kidney injury or failure or nearly anuria more than 2hr or late conventional dialysis indication', 'armGroupLabels': ['early crrt, late crrt']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'sangbum hong, md', 'role': 'CONTACT', 'email': 'sbhong@amc.seoul.kr', 'phone': '82-2-3010-3893'}, {'name': 'sangbum hong, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'sangbum hong, md', 'role': 'CONTACT', 'email': 'sbhong@amc.seoul.kr', 'phone': '82-2-3010-3893'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'sangbum hong', 'oldOrganization': 'Asan Medical Center'}}}}