Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT04871893
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2021-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D006935', 'term': 'Hypercapnia'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, non-comparative, multi-centre, open-label, interventional PMCF study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical efficiency variables: Change of PaCO2', 'timeFrame': '30 minutes after start of treatment', 'description': 'Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA))'}], 'secondaryOutcomes': [{'measure': 'Technical efficiency variables: Change of pCO2', 'timeFrame': '72 hours after start of treatment', 'description': 'Change of pCO2 within the extracorporeal circuit by pre- and post- CO2-exchanger during the treatment (Blood-gas analysis (BGA))'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CO2 removal', 'Continuous Renal Replacement Therapy', 'blood-gas exchanger', 'CRRT', 'multiECCO2R'], 'conditions': ['Acute Lung Injury', 'Acute Kidney Injury', 'Hypercapnia', 'Covid19']}, 'descriptionModule': {'briefSummary': 'Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal replacement therapy (CRRT) in patients presenting with hypercapnia due to acute lung failure and acute kidney injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed and dated by the investigator; and:\n\n 1. if patient is able to give consent: by the study patient\n 2. if patient is unable to give consent: by the legal representative or\n 3. if an emergency situation is determined: by an independent consultant physician\n* Minimum age of 18 years\n\nStudy-specific:\n\n* Body weight greater than 40 kg\n* Acute Kidney Injury (AKI) with clinical indication for CRRT\n* Hypercapnia with indication for ECCO2R:\n\n(paCO2 ≥ 55 mmHg at given best possible protective ventilation parameters: Guiding parameters: tidal volume = 6 ml/kg PBW, PEEP to be adjusted according to the FiO2 1, driving pressure \\< 15 cmH2O, max. inspiratory pressure \\< 30 cmH2O or TV\\<=5 ml/kg when max. inspiratory pressure\\< 30 cmH2O cannot be held)\n\n* Vascular access and Shaldon catheter allowing blood flow of 100 ml/min to 500 ml/min\n* Arterial line in place, allowing blood sampling\n* Estimated life expectancy greater than 3 days\n\nExclusion Criteria:\n\n* In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required)\n* Participation in an interventional clinical study during the preceding 72 hours\n* Previous participation in the same study\n\nStudy-specific\n\n* Severe ARDS (Berlin definition): PaO2/FiO2 \\< 100 mmHg\n* Intracerebral haemorrhage\n* Intracranial hypertension\n* Acute myocardial infarction\n* Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II), if heparin is used as anticoagulant\n* severe liver insufficiency or fulminant hepatic failure\n* Uncontrolled bleeding and coagulation disorders, thrombocytopenia \\< 75000µL\n* Liver cirrhosis CHILD Pugh Classification \\> A\n* BMI \\> 40 kg/m²\n* Decision to limit therapeutic interventions'}, 'identificationModule': {'nctId': 'NCT04871893', 'acronym': 'multiECCO2R', 'briefTitle': 'Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care Deutschland GmbH'}, 'officialTitle': 'Safety and Effcacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy (A Clinical Study in Patients With Combined Renal Failure and Hypercapnia Due to Acute Lung Failure in COVID-19 and Other Forms of Respiratory Insufficiency)', 'orgStudyIdInfo': {'id': 'CRRT-CVVHD/HDF-01-D'}, 'secondaryIdInfos': [{'id': 'CIV-21-03-035951', 'type': 'OTHER', 'domain': 'Unique identification number EUDAMED'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment with the blood-gas exchanger multiECCO2R for CO2 removal', 'description': 'Treatment of patients suffering from hypercapnia due to acute lung failure and acute kidney injury (AKI). Patients will be treated up to 72 hours with CVVHD/HDF with a standard multiFiltrate blood line kit (multiFiltrate or multiFiltrate Pro). In order to perform an ECCO2R procedure during CVVHD/HDF treatment, the blood-gas exchanger multiECCO2R is inserted in a specifically designed blood line kit downstream of the hemodialyzer.', 'interventionNames': ['Device: multiECCO2R blood-gas exchanger']}], 'interventions': [{'name': 'multiECCO2R blood-gas exchanger', 'type': 'DEVICE', 'description': 'Treatment with the blood-gas exchanger multiECCO2R for CO2 removal', 'armGroupLabels': ['Treatment with the blood-gas exchanger multiECCO2R for CO2 removal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '93093', 'city': 'Donaustauf', 'country': 'Germany', 'facility': 'Klinikum Donaustauf', 'geoPoint': {'lat': 49.03258, 'lon': 12.20459}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '32049', 'city': 'Herford', 'country': 'Germany', 'facility': 'Klinikum Herford', 'geoPoint': {'lat': 52.11457, 'lon': 8.67343}}], 'overallOfficials': [{'name': 'Thomas Müller, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin'}, {'name': 'Matthias Lubnow, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Medical Care Deutschland GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CERES GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}