Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-05 @ 5:15 PM
Study NCT ID:
NCT03507751
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2018-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Meropenem During High-dose CRRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples for obtaining meropenem concentrations'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2019-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2018-04-15', 'studyFirstSubmitQcDate': '2018-04-15', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of meropenem', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Infection', 'Renal Failure']}, 'descriptionModule': {'briefSummary': 'Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours.', 'detailedDescription': "This is a prospective observational study performed on critically ill patients. Inclusion criteria are a severe infection on admission requiring the use of meropenem and CRRT.\n\nBoth medical and surgical patients will be included. Any type of infections can be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes one-hour infusion of meropenem (1.0 gram) intravenously every 8 hours.\n\nBlood samples (2 mL) will be collected at the 15, 30, 45, 60, 75, 90, 120, 180, 240, and 480 minutes after each dose of meropenem for 3 consecutive days. The standard arterial canula will be used to obtain samples.\n\n30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.\n\nSerum meropenem concentration will be measured by high-performance liquid chromatography.\n\nEach patient's hemodynamic parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies, i.e. ventilatory support, sedation, an antifungal agent will be given as required."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severely ill patients treated in ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who require ICU treatment due to severe infection\n* age 18-80 years\n* an eligible consent obtained from the patient or his/her attendant\n\nExclusion Criteria:\n\n* allergy to meropenem\n* lack of consent to participate in the study\n* age of patients below 18 or above 80 years'}, 'identificationModule': {'nctId': 'NCT03507751', 'briefTitle': 'Pharmacokinetics of Meropenem During High-dose CRRT', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lublin'}, 'officialTitle': 'Pharmacokinetics of Meropenem During High-dose Continuous Renal Replacement Therapy in Critically Ill Patients', 'orgStudyIdInfo': {'id': '90/2009/IV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Meropenem', 'description': 'Patients who require meropenem and CRRT during ICU (intensive care unit) stay', 'interventionNames': ['Drug: Meropenem', 'Device: CRRT']}], 'interventions': [{'name': 'Meropenem', 'type': 'DRUG', 'description': '1.0 gram of meropenem given intravenously every 8 hours', 'armGroupLabels': ['Meropenem']}, {'name': 'CRRT', 'type': 'DEVICE', 'description': 'Continuous renal replacement therapy for three days', 'armGroupLabels': ['Meropenem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10- 561', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Oddział Kliniczny Anestezjologii i Intensywnej Terapii, Wojewódzki Szpital Specjalistyczny w Olsztynie', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lublin', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Warmia and Mazury in Olsztyn', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Michał Borys', 'investigatorAffiliation': 'Medical University of Lublin'}}}}