Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-28 @ 10:37 AM
Study NCT ID:
NCT01911533
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2013-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2014-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2013-07-23', 'studyFirstSubmitQcDate': '2013-07-26', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain a reduction of 20% in arterial partial CO2 pressure (PaCO2) after the first two hours of ECCO2-R therapy.', 'timeFrame': 'After the first two hours of ECCO2-R therapy, every 2 hours for a maximum of 5 days.', 'description': 'Arterial blood gasses, ventilator settings will be measured.'}], 'secondaryOutcomes': [{'measure': 'Reduction in Plateau pressures to levels between 25 and 28 cm H2O.', 'timeFrame': 'Every 2 hours during procedure for a maximum of 5 days.', 'description': 'Arterial blood gasses and ventilator settings will be measured.'}, {'measure': '• Reduction in tidal volumes to 6ml/kg predicted body weight (PBW) or lower, with a minimum of 3ml/kg PBW.', 'timeFrame': 'Every 2 hours during the procedure for a maximum of 5 days.', 'description': 'Arterial blood gasses and ventilator settings will be measured.'}, {'measure': 'Increase in pH to the normal range of 7,35 to 7,45.', 'timeFrame': 'Every 2 hours during the procedure for a maximum of 5 days.', 'description': 'Arterial blood gasses and ventilator settings will be measured.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['ACUTE RESPIRATORY DISTRESS SYNDROME']}, 'referencesModule': {'references': [{'pmid': '29179681', 'type': 'DERIVED', 'citation': 'Peperstraete H, Eloot S, Depuydt P, De Somer F, Roosens C, Hoste E. Low flow extracorporeal CO2 removal in ARDS patients: a prospective short-term crossover pilot study. BMC Anesthesiol. 2017 Nov 28;17(1):155. doi: 10.1186/s12871-017-0445-9.'}], 'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Hypothesis:\n\nExtracorporeal removal of CO2 can treat hypercapnia and respiratory acidosis, which allows application of lung protective ventilation. This downgrading of mechanical ventilation promotes better and more quickly lung recovery.\n\nAim:\n\nThe aim of the study is to treat respiratory acidosis and to reduce plateau pressures by using an extracorporeal removal of CO2 (ECCO2-R).\n\nThis prospective study will include 10 patients with an Acute Respiratory Distress Syndrome (ARDS). ARDS is an inflammatory response in the lungs, the onset is acute with pulmonary oedema and shows bilateral densities on chest radiography. The take up of oxygen and the loss of CO2 in the lungs are difficult. Moreover the patient's blood can become acidic due to too much CO2.\n\nTo promote a better gas-exchange, the patient with ARDS will be mechanically ventilated. This can be aggressive and harmful for the lungs. With the use of an extra-corporeal CO2-remover, CO2 can be removed so that the mechanical ventilation setting will be less aggressive and will decrease lesions in the lung. The veno-venous extracorporeal CO2-remover pumps blood from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood and extracts carbon dioxide from the blood) and back into a vein.\n\nThe investigators will use a standard dialysis catheter that will be put in a large vein. To prevent clotting of the system, the patient will receive heparin.\n\nIn the study the investigators will work in periods of two hours, the situation before and after carbon dioxide removal will be compared. With this study the investigators want to prove that the CO2 in the blood decreases with at least 20 % with the use of the extracorporeal CO2 remover. More over the investigators want to prove that lower mechanical ventilation settings (thanks to CO2-removal by the ECCO2-R) will produce fewer lesions to the lungs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Acute onset of ARDS criteria on chest X-ray or CT scan\n* Moderate (PaO2/ FiO2 \\<200) or severe ARDS (PaO2/ FiO2 \\<100) (FiO2: fraction of inspired oxygen)\n* Respiratory acidosis with pH\\< 7,25,\n* With plateau pressure of 28cmH20 or higher,\n\nExclusion criteria:\n\n* \\<18 years of age\n* Pregnancy\n* Obesity with BMI\\> 30\n* Contraindication for anticlotting therapy\n* Chest wall abnormalities\n* No presumed consent of representatives'}, 'identificationModule': {'nctId': 'NCT01911533', 'briefTitle': 'Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis.', 'orgStudyIdInfo': {'id': '2013/505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'extracorporeal CO2', 'interventionNames': ['Procedure: extracorporeal removal of CO2 (ECCO2-R)', 'Procedure: No extracorporeal CO2-removal']}], 'interventions': [{'name': 'extracorporeal removal of CO2 (ECCO2-R)', 'type': 'PROCEDURE', 'description': 'To promote a better gas-exchange, the patient with ARDS will be mechanically ventilated. This can be aggressive and harmful for the lungs. With the use of an extra-corporeal CO2-remover, CO2 can be removed so that the mechanical ventilation setting will be less aggressive and will decrease lesions in the lung. The veno-venous extracorporeal CO2-remover pumps blood from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood and extracts carbon dioxide from the blood) and back into a vein.', 'armGroupLabels': ['extracorporeal CO2']}, {'name': 'No extracorporeal CO2-removal', 'type': 'PROCEDURE', 'description': 'Patients are their own control group.', 'armGroupLabels': ['extracorporeal CO2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Harlinde Peperstraete, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}