Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 5:36 PM
Study NCT ID:
NCT01582360
Status:
UNKNOWN
Last Update Posted:
2015-10-16
First Post:
2012-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 640}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-14', 'studyFirstSubmitDate': '2012-04-19', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sub-therapeutic levels of measured antiinfectiva', 'timeFrame': '72 hours', 'description': 'Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva'}], 'secondaryOutcomes': [{'measure': 'SOFA-score', 'timeFrame': '72 hrs', 'description': 'Sequential organ failure assessment, first 3 days after initiation of therapy'}, {'measure': 'Mortality', 'timeFrame': '90-days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['critical illness', 'pharmacokinetics', 'CRRT', 'CVVH', 'CVVHD', 'CVVHDF', 'antiinfectives', 'antibiotics', 'minimum inhibitory concentration', 'bacterial killing', 'pharmacodynamics', 'PK/PD index'], 'conditions': ['Critically Ill', 'Acute Renal Failure', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.\n\nThe effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.\n\nHypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.', 'detailedDescription': 'The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.\n\nThe effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.\n\nHypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.\n\nThe antiinfectives to be examined are meropenem, fluconazol, cefotaxim, ciprofloxacin, tazobactam-piperacillin, vancomycin,penicillin,cloxacillin.\n\nEndpoints:\n\n1. Measured plasma concentrations of antiinfectives are sufficient for maximal microbial killing.\n2. To identify the most important variability factors for plasma concentrations of antiinfectives in patients receiving CRRT\n3. Establish and validate a routine for measurement of vital antiinfectives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients admitted to the ICU at Oslo University Hospital, in need of treatment with antiinfectives.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted to ICU in need of antiinfectives:\n\n 1. in need of CRRT\n 2. without acute kidney failure\n2. requirement for antiinfectives\\> 72 hrs\n3. Age \\> 18 yrs\n4. signed informed consent\n\nExclusion Criteria:\n\n1. Acute or chronic renal failure not in need of CRRT\n2. Age \\< 18 yrs'}, 'identificationModule': {'nctId': 'NCT01582360', 'acronym': 'PharmacoCRRT', 'briefTitle': '2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT', 'orgStudyIdInfo': {'id': '2011/10076'}, 'secondaryIdInfos': [{'id': '2011/10076 (OUSH)', 'type': 'OTHER', 'domain': '2011/10076 (Oslo University Hospital)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'antiinfectiva: vancomycin', 'description': '80 patients Completed.'}, {'label': 'antiinfectiva: meropenem', 'description': '80 patients recruiting'}, {'label': 'antiinfectiva: flukonazol', 'description': '80 patients'}, {'label': 'antiinfectiva: cefotaxim', 'description': '80 patients'}, {'label': 'antiinfectiva: benzylpenicilline', 'description': '80 patients'}, {'label': 'antiinfectiva: tazobactam piperacillin', 'description': '80 patients recruiting'}, {'label': 'antiinfectiva: cloxacillin', 'description': '80 patients'}, {'label': 'antiinfectiva: ciprofloxacin', 'description': '80 patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Elin Helset, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jan Fr Bugge, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hilde Ma Sporsem, cand pharm', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yvonne Lao, cand pharm', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kirsti Andersson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Elin Helset, MD PhD', 'role': 'CONTACT', 'email': 'ehj@ous-hf.no', 'phone': '+4722119585'}], 'overallOfficials': [{'name': 'Elin Helset, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital'}, {'name': 'Jan Fr Bugge, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}, {'name': 'Elizabeth von der Lippe, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}, {'name': 'Hilde Ma Sporsem, cand pharm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sykehusapotekene Oslo'}, {'name': 'Yvonne Lao, cand pharm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sykehusapotekene Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}