Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT00948558
Status:
UNKNOWN
Last Update Posted:
2009-08-06
First Post:
2009-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009102', 'term': 'Multiple Organ Failure'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-04', 'studyFirstSubmitDate': '2009-07-28', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['citrate anticoagulation', 'pharmacokinetic', 'critically ill', 'acute kidney failure'], 'conditions': ['Acute Kidney Failure With or Without:', 'MODS', 'Sepsis', 'Hepatic Insufficiency']}, 'referencesModule': {'references': [{'pmid': '23824037', 'type': 'DERIVED', 'citation': 'Zheng Y, Xu Z, Zhu Q, Liu J, Qian J, You H, Gu Y, Hao C, Jiao Z, Ding F. Citrate Pharmacokinetics in Critically Ill Patients with Acute Kidney Injury. PLoS One. 2013 Jun 18;8(6):e65992. doi: 10.1371/journal.pone.0065992. Print 2013.'}]}, 'descriptionModule': {'briefSummary': '1. To compare the differences of citrate pharmacokinetics in healthy individuals and critically ill patients as well as the influential factors.\n2. To validate a pharmacokinetic model which has been established in a formal paper.\n3. To create a safe and effective RCA-CRRT protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the subjects will be selected from a university teaching hospital in Shanghai, China.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individuals, none-pregnant\n* diagnosed with acute renal failure according to RIFLE criteria\n* ARF with hepatic insufficiency\n* ARF with MODS or sepsis\n* within informed consent\n\nExclusion Criteria:\n\n* used drugs with citrate within one week\n* infused with blood,plasma or platelet or undergone plasma exchange therapy within 48 hours\n* serious alkalosis with PH\\>7.55\n* serious lactic acidosis\n* not in resuscitation state'}, 'identificationModule': {'nctId': 'NCT00948558', 'briefTitle': 'Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Citrate Pharmacokinetics in Healthy Individuals and Critically Ill Patients and the Application of Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy(RCA-CRRT).', 'orgStudyIdInfo': {'id': 'KY2009-108'}}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Ding, doctor', 'role': 'CONTACT', 'email': 'ding_feng@hotmail.com', 'phone': '81-02152888135'}], 'facility': 'Huashan hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Feng Ding, Professor', 'role': 'CONTACT', 'email': 'ding_feng@hotmail.com', 'phone': '86-02152888135'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Scientific and technology committe', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Feng Ding', 'oldOrganization': 'Huashan Hospital'}}}}