Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
Study NCT ID:
NCT03560557
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, serum, urine, bronchoalveolar lavage fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk factors for target non attainment', 'timeFrame': 'on day of sampling', 'description': "risk factors will be assessed by comparing patients who attain target vs. those who don't"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Meropenem', 'Critical illness', 'Capillary leak', 'Augmented renal clearance'], 'conditions': ['Critical Illness', 'Pharmacokinetics']}, 'referencesModule': {'references': [{'pmid': '35035223', 'type': 'DERIVED', 'citation': 'Gijsen M, Elkayal O, Annaert P, Van Daele R, Meersseman P, Debaveye Y, Wauters J, Dreesen E, Spriet I. Meropenem Target Attainment and Population Pharmacokinetics in Critically Ill Septic Patients with Preserved or Increased Renal Function. Infect Drug Resist. 2022 Jan 8;15:53-62. doi: 10.2147/IDR.S343264. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'WP1.1. PK/PD target attainment: Plasma exposure, Excretion via urine \\& ELF exposure; WP1.2. Predictive dosing algorithm; WP1.3. ECMO subset', 'detailedDescription': 'First, the investigators will document exposure to meropenem in plasma and epithelial lining fluid. Moreover excretion in urine will be documented.\n\nSecond, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed.\n\nFinally in a small subset of ECMO patients PK exposure will be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients with sepsis and receiving meropenem', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe sepsis or septic shock\n* Admitted to an ICU ward\n* Treated with meropenem\n\nExclusion Criteria:\n\n* eGFR(CKD-EPI) \\< 70ml/min/1.73m²\n* Renal replacement therapy\n* Pregnancy\n* DNR code 1-3'}, 'identificationModule': {'nctId': 'NCT03560557', 'briefTitle': 'Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis', 'orgStudyIdInfo': {'id': 'ML8459'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Isabel Spriet, PharmD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'To be discussed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PharmD', 'investigatorFullName': 'Matthias Gijsen', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}