Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT01627756
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2012-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continued Ventilation During Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014691', 'term': 'Ventilation'}], 'ancestors': [{'id': 'D004780', 'term': 'Environment, Controlled'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-06-25', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alteration of soluble ST2 concentration in serum', 'timeFrame': 'Preoperative, postoperative, day 1, day 2, day 3, day 4, day 5 after surgery', 'description': 'Concentration of soluble ST2 will be assessed in the serum of patient´s preoperativem, postoperative and the following five consecutive days after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thoracic Surgery', 'Endotoxins', 'Respiration, Artificial', 'Immune System'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '19169993', 'type': 'BACKGROUND', 'citation': 'Szerafin T, Niederpold T, Mangold A, Hoetzenecker K, Hacker S, Roth G, Lichtenauer M, Dworschak M, Wolner E, Ankersmit HJ. Secretion of soluble ST2 - possible explanation for systemic immunosuppression after heart surgery. Thorac Cardiovasc Surg. 2009 Feb;57(1):25-9. doi: 10.1055/s-2008-1039044. Epub 2009 Jan 23.'}, {'pmid': '18154785', 'type': 'BACKGROUND', 'citation': 'Szerafin T, Hoetzenecker K, Hacker S, Horvath A, Pollreisz A, Arpad P, Mangold A, Wliszczak T, Dworschak M, Seitelberger R, Wolner E, Ankersmit HJ. Heat shock proteins 27, 60, 70, 90alpha, and 20S proteasome in on-pump versus off-pump coronary artery bypass graft patients. Ann Thorac Surg. 2008 Jan;85(1):80-7. doi: 10.1016/j.athoracsur.2007.06.049.'}, {'pmid': '16812952', 'type': 'BACKGROUND', 'citation': 'Szerafin T, Horvath A, Moser B, Hacker S, Hoetzenecker K, Steinlechner B, Brunner M, Roth G, Boltz-Nitulescu G, Peterffy A, Wolner E, Ankersmit HJ. Apoptosis-specific activation markers in on- versus off-pump coronary artery bypass graft (CABG) patients. Clin Lab. 2006;52(5-6):255-61.'}, {'pmid': '16329625', 'type': 'BACKGROUND', 'citation': 'Szerafin T, Brunner M, Horvath A, Szentgyorgyi L, Moser B, Boltz-Nitulescu G, Peterffy A, Hoetzenecker K, Steinlechner B, Wolner E, Ankersmit HJ. Soluble ST2 protein in cardiac surgery: a possible negative feedback loop to prevent uncontrolled inflammatory reactions. Clin Lab. 2005;51(11-12):657-63.'}, {'pmid': '20363761', 'type': 'BACKGROUND', 'citation': 'Mildner M, Storka A, Lichtenauer M, Mlitz V, Ghannadan M, Hoetzenecker K, Nickl S, Dome B, Tschachler E, Ankersmit HJ. Primary sources and immunological prerequisites for sST2 secretion in humans. Cardiovasc Res. 2010 Sep 1;87(4):769-77. doi: 10.1093/cvr/cvq104. Epub 2010 Apr 2.'}, {'pmid': '18154801', 'type': 'BACKGROUND', 'citation': 'Ng CS, Arifi AA, Wan S, Ho AM, Wan IY, Wong EM, Yim AP. Ventilation during cardiopulmonary bypass: impact on cytokine response and cardiopulmonary function. Ann Thorac Surg. 2008 Jan;85(1):154-62. doi: 10.1016/j.athoracsur.2007.07.068.'}, {'pmid': '25226360', 'type': 'DERIVED', 'citation': 'Beer L, Szerafin T, Mitterbauer A, Debreceni T, Maros T, Dworschak M, Roth GA, Ankersmit HJ. Low tidal volume ventilation during cardiopulmonary bypass reduces postoperative chemokine serum concentrations. Thorac Cardiovasc Surg. 2014 Dec;62(8):677-82. doi: 10.1055/s-0034-1387824. Epub 2014 Dec 15.'}, {'pmid': '24343370', 'type': 'DERIVED', 'citation': 'Beer L, Szerafin T, Mitterbauer A, Kasiri MM, Debreceni T Palotas L, Dworschak M, Roth GA, Ankersmit HJ. Ventilation during cardiopulmonary bypass: impact on heat shock protein release. J Cardiovasc Surg (Torino). 2014 Dec;55(6):849-56. Epub 2013 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'Cardiopulmonary bypass (CPB) is well known to induce a strong anti-inflammatory response. The investigators examined whether continued mechanical ventilation during CPB alters systemic immune activation.', 'detailedDescription': 'Cardiopulmonary bypass is well known to induce a strong anti-inflammatory response. Studies had been shown that the contact of blood components with artificial surfaces, the surgical trauma, endotoxemia and a reperfusion injury are in part responsible for the seen immunological affect after surgery. The purpose of this study is to test the effect of continued mechanical ventilation during surgery on a blood marker called soluble ST2 in patients sera. Soluble ST2 acts as a decoy receptor of IL-33 and has anti-inflammatory effects. Elevated soluble ST2 concentrations are reported in patients with acute myocardial infarction, sepsis, congestive heart failure and elevates soluble ST2 levels are associated with adverse outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* age \\> 40 and \\< 80\n\nExclusion Criteria:\n\n* treatment with steroids or immunomodulatory interventions during the past four weeks\n* signs of an acute infection'}, 'identificationModule': {'nctId': 'NCT01627756', 'briefTitle': 'Continued Ventilation During Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Continued Mechanical Ventilation During CABG Operation Attenuates Systemic Immune Modulation', 'orgStudyIdInfo': {'id': '2894-2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ventilation Group', 'description': 'Volume controlled ventilation was done during the whole surgery.', 'interventionNames': ['Other: Lung Ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-ventilation Group', 'description': 'In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.', 'interventionNames': ['Other: Non-ventilated Group']}], 'interventions': [{'name': 'Lung Ventilation', 'type': 'OTHER', 'description': 'In the ventilated group, mechanical ventilation was done with the half of the initial tidal volume (i.e. 3-4 ml/kg, 250-300ml) during the aortic cross-clamp.', 'armGroupLabels': ['Ventilation Group']}, {'name': 'Non-ventilated Group', 'type': 'OTHER', 'description': '. In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.', 'armGroupLabels': ['Non-ventilation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Nagyerdei krt. 98', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Medical University of Debrecen', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}], 'overallOfficials': [{'name': 'Hendrik Jan Ankersmit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof', 'investigatorFullName': 'Hendrik Jan Ankersmit', 'investigatorAffiliation': 'Medical University of Vienna'}}}}