Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT05044403
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2021-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009102', 'term': 'Multiple Organ Failure'}, {'id': 'D018805', 'term': 'Sepsis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006464', 'term': 'Hemoperfusion'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-6 plasmatic concentration', 'timeFrame': 'During hemoperfusion', 'description': "Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process"}, {'measure': 'Adverse events', 'timeFrame': 'During hemoperfusion', 'description': 'Analyze the presence of adverse events during the hemoperfusion process'}, {'measure': 'Organ failure', 'timeFrame': 'During hemoperfusion', 'description': 'Analyze the number and severity of failed organs during the hemoperfusion process'}, {'measure': 'Vasopressors dose', 'timeFrame': 'During hemoperfusion', 'description': "Analyze the patient's vasopressor dose variation during the hemoperfusion process"}, {'measure': 'Mean arterial pressure', 'timeFrame': 'During hemoperfusion', 'description': "Analyze the patient's variation of mean arterial pressure during hemoperfusion"}, {'measure': 'Vasopressors dose', 'timeFrame': 'During ICU stay', 'description': 'Analyze the number of days on vasopressor support during ICU stay'}, {'measure': 'Mechanical ventilation', 'timeFrame': 'During ICU stay', 'description': 'Analyze the number of days on mechanical ventilation during ICU stay'}, {'measure': 'Renal replacement therapy', 'timeFrame': 'During ICU stay', 'description': 'Analyze the number of days on renal replacement therapy during ICU stay'}, {'measure': 'ICU length of stay', 'timeFrame': 'Post-Intensive Care Unit discharge', 'description': "Analyze the patient's length of stay in ICU"}, {'measure': 'ICU survival', 'timeFrame': 'Post-Intensive Care Unit discharge', 'description': "Analyze the patient's survival in ICU"}, {'measure': 'Hospital stay', 'timeFrame': 'post-hospital discharge', 'description': "Analyze the patient's length of stay post-Intensive Care Unit discharge"}, {'measure': 'Hospital survival', 'timeFrame': 'Post-hospital discharge', 'description': "Analyze the patient's survival post-hospital discharge"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemoperfusion', 'Multiorgan Failure', 'Sepsis']}, 'descriptionModule': {'briefSummary': 'Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:\n* Sepsis of abdominal origin with controlled infectious focus.\n* Noradrenaline dose\\> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy.\n* Dysfunction of two or more organs with SOFA ≥ 9 (5).\n* Blood lactate ≥ 2 mmol / L.\n* Procalcitonin (PCT)\\> 10 ng / mL.\n* CRP\\> 100 mg / L.\n* IL-6\\> 2000 pg / ml.\n\nExclusion Criteria:\n\n* Age under 18 years or over 80 years.\n* Pregnancy or breastfeeding.\n* Terminally ill patients or with a life expectancy of less than 48 hours.\n* Thrombocytopenia \\<60,000 / mm3.\n* Pancytopenia.\n* Severe coagulopathy with high risk of bleeding.\n* Inclusion in another research protocol.\n* In case of re-entry during the study period, only the first admission will be included.\n* Use of another haemoperfusion device.'}, 'identificationModule': {'nctId': 'NCT05044403', 'briefTitle': 'Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Clinical Impact of Hemoperfusion With a Neutral Macroporous Resin Cartridge as Adjunctive Treatment in Septic Patients With Multiorgan Dysfunction Syndrome (MODS) Admitted to Intensive Care Units.', 'orgStudyIdInfo': {'id': 'MUL-HEMO-2021-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'description': 'Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.', 'interventionNames': ['Procedure: Conventional treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Extracorporeal support with haemoperfusion treatment', 'description': 'Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin.', 'interventionNames': ['Procedure: Extracorporeal support with haemoperfusion']}], 'interventions': [{'name': 'Extracorporeal support with haemoperfusion', 'type': 'PROCEDURE', 'description': 'Use of extracorporeal support with haemoperfusion', 'armGroupLabels': ['Extracorporeal support with haemoperfusion treatment']}, {'name': 'Conventional treatment', 'type': 'PROCEDURE', 'description': 'Conventional treatment', 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12004', 'city': 'Castellon', 'state': 'Castellón', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando Sanchez Moran', 'role': 'CONTACT', 'email': 'sanchez_fermor@gva.es'}], 'facility': 'Hospital General Universitario de Castellon', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}], 'centralContacts': [{'name': 'Fernando Sánchez Morán', 'role': 'CONTACT', 'email': 'sanchez_fermor@gva.es', 'phone': '964399914'}], 'overallOfficials': [{'name': 'Fernando Sanchez Moran', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario de Castellon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Background Abdominal sepsis remains a major challenge in critical care, often associated with high morbidity and mortality. Hemoadsorption therapy has been proposed as a strategy to modulate the systemic inflammatory response in septic patients. However, clinical evidence in the abdominal sepsis population is limited.\n\nConclusions Haemoadsorption appears to be a feasible and safe intervention in patients with abdominal sepsis. Preliminary results suggest potential benefits in inflammatory modulation, organ function improvement, and mortality reduction. Larger, more robust clinical trials are required to confirm efficacy and clarify its impact on clinical outcomes. A more comprehensive and detailed analysis of the results will be provided upon completion of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital General Universitario de Castellón', 'class': 'OTHER'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Hospital de Granollers', 'class': 'OTHER'}, {'name': 'Hospital General Universitario Santa Lucía', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}