Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-01 @ 12:23 AM
Study NCT ID:
NCT02564406
Status:
COMPLETED
Last Update Posted:
2016-07-22
First Post:
2015-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal CO2 Removal in Hypercapnic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2015-09-26', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients who avoided endotracheal intubation', 'timeFrame': '60 days'}], 'secondaryOutcomes': [{'measure': 'Gas exchange homeostasis', 'timeFrame': '96 hrs', 'description': 'pH, PaCO2, PaO2, bicarbonate, arterial lactate'}, {'measure': 'Norepinephrine requirements', 'timeFrame': '30 days', 'description': 'norepinephrine requirements in the patients who due to clinical conditions were under norepinephrine before starting the treatment with extracorporeal Co2 removal'}, {'measure': 'coagulation', 'timeFrame': '30 days', 'description': 'INR, pt, ptt. platelets'}, {'measure': 'Day 28 mortality', 'timeFrame': '28 days'}, {'measure': 'intra hospital mortality', 'timeFrame': '180 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '23460154', 'type': 'BACKGROUND', 'citation': 'Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.'}, {'pmid': '25230375', 'type': 'BACKGROUND', 'citation': "Del Sorbo L, Pisani L, Filippini C, Fanelli V, Fasano L, Terragni P, Dell'Amore A, Urbino R, Mascia L, Evangelista A, Antro C, D'Amato R, Sucre MJ, Simonetti U, Persico P, Nava S, Ranieri VM. Extracorporeal Co2 removal in hypercapnic patients at risk of noninvasive ventilation failure: a matched cohort study with historical control. Crit Care Med. 2015 Jan;43(1):120-7. doi: 10.1097/CCM.0000000000000607."}]}, 'descriptionModule': {'briefSummary': 'Noninvasive ventilation represents the standard of care for patients with exacerbation of chronic obstructive pulmonary disease. However, NIV fails in almost 30% of the most severe forms of acute hypercapnic respiratory failure and patients must undergo endotracheal intubation and invasive ventilation to restore adequate gas exchange. Under these circumstances, patients may express a clear intention not to be intubated.The aim of this study is to retrospectively assess efficacy and safety of noninvasive ventilation- plus-extracorporeal Co2 removal in patients who fail NIV and refuse endotracheal intubation.', 'detailedDescription': 'During a period of two years (from January 2013 to July 2015) 35 patients with acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease, refused endotracheal intubation after failing NIV and were treated with extracorporeal Co2 removal plus NIV as last resort therapy.\n\nThe collected data of these patients will be retrospectively matched with data obtained from 35 historical controls who received conventional treatment with endotracheal intubation. The study will retrospectively compare intubation rate, acid base homeostasis, norepinephrine requirements (in the patients who due to clinical conditions were under norepinephrine before starting extracorporeal Co2 removal ) and coagulation parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* exacerbation of chronic obstructive pulmonary disease\n* failure of non invasive ventilation\n* expression of a clear intention not to be intubated\n\nExclusion Criteria:\n\n* alterations in mental status which do not allow to express a clear intention not to be intubated\n* contraindications to anticoagulation'}, 'identificationModule': {'nctId': 'NCT02564406', 'briefTitle': 'Extracorporeal CO2 Removal in Hypercapnic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Extracorporeal CO2 Removal in Hypercapnic Patients Who Failed Noninvasive Ventilation and Refuse Endotracheal Intubation: a Case Series', 'orgStudyIdInfo': {'id': '3785'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hypercapnic patients', 'description': 'patients with acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease, refused endotracheal intubation after failing NIV and were treated withLow flow etracorporeal CO2 removal', 'interventionNames': ['Device: LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR']}], 'interventions': [{'name': 'LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR', 'type': 'DEVICE', 'armGroupLabels': ['hypercapnic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Dept of Anesthesiology and Intensive Care', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Andrea Morelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Roma La Sapienza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD. Associate professor', 'investigatorFullName': 'Andrea Morelli', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}