Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04533256
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2020-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-days mortality', 'timeFrame': '28 days after ICU admission', 'description': '28-days mortality'}], 'secondaryOutcomes': [{'measure': 'severity score', 'timeFrame': '3 days', 'description': 'dynamics of SOFA score (Sequential Organ Failure Assessment) calculated as the mathematical difference in post-therapy SOFA score and pre-therapy SOFA score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['organ failure', 'renal replacement therapy', 'hemoadsorption'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Hemoadsorption has been demonstrated to improve clinical and paraclinical results in critically ill patients with sepsis and septic shock. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with sepsis, on organ failure, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with sepsis or septic shock who require hemoadsorption in accordance with local guidelines. The decision of hemoadsorption is made by the attending physician prior to study inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with sepsis or septic shock who require hemoadsorption in accordance with local guidelines\n\nExclusion Criteria:\n\n* unsigned informed consent\n* duration of therapy under 12 hours\n* death before the three consecutive sessions'}, 'identificationModule': {'nctId': 'NCT04533256', 'briefTitle': 'Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Institutul Clinic Fundeni'}, 'officialTitle': 'Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Sepsis', 'orgStudyIdInfo': {'id': 'Cyto-Sepsis'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CytoSorb', 'type': 'PROCEDURE', 'description': 'three consecutive sessions of hemoadsorption in patients with sepsis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '022328', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Fundeni Clinical Institute', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Dana Tomescu, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Fundeni Clinical Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institutul Clinic Fundeni', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Popescu Mihai', 'investigatorAffiliation': 'Institutul Clinic Fundeni'}}}}