Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT01614951
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2012-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Pulmonary Protection Trial
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C039984', 'term': 'Bretschneider cardioplegic solution'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-24', 'studyFirstSubmitDate': '2012-06-06', 'studyFirstSubmitQcDate': '2012-06-07', 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygenation Index', 'timeFrame': 'From pre operation until 24 hours post operation', 'description': 'To investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation index after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Obstructive Lung Disease']}, 'referencesModule': {'references': [{'pmid': '30879046', 'type': 'DERIVED', 'citation': 'Risom EC, Buggeskov KB, Mogensen UB, Sundskard M, Mortensen J, Ravn HB. Preoperative pulmonary function in all comers for cardiac surgery predicts mortalitydagger. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):244-251. doi: 10.1093/icvts/ivz049. Epub 2019 Mar 15.'}, {'pmid': '27651908', 'type': 'DERIVED', 'citation': 'Buggeskov KB, Sundskard MM, Jonassen T, Andersen LW, Secher NH, Ravn HB, Steinbruchel DA, Jakobsen JC, Wetterslev J. Pulmonary artery perfusion versus no pulmonary perfusion during cardiopulmonary bypass in patients with COPD: a randomised clinical trial. BMJ Open Respir Res. 2016 Sep 6;3(1):e000146. doi: 10.1136/bmjresp-2016-000146. eCollection 2016.'}, {'pmid': '25539792', 'type': 'DERIVED', 'citation': 'Buggeskov KB, Jakobsen JC, Secher NH, Jonassen T, Andersen LW, Steinbruchel DA, Wetterslev J. Detailed statistical analysis plan for the pulmonary protection trial. Trials. 2014 Dec 23;15:510. doi: 10.1186/1745-6215-15-510.'}, {'pmid': '23363494', 'type': 'DERIVED', 'citation': 'Buggeskov KB, Wetterslev J, Secher NH, Andersen LW, Jonassen T, Steinbruchel DA. Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial. Trials. 2013 Jan 31;14:30. doi: 10.1186/1745-6215-14-30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation capacity after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Planned and urgent surgery on legally competent patients over 18 years:\n\n * Coronary Artery Bypass Graft Surgery\n * Aortic Valve Replacement\n * Coronary Artery Bypass Graft Surgery + Aortic Valve Replacement\n * Transcatheter Aortic-Valve Implantation\n2. Spirometry FEV1 measurement show less than or equal to 80% of the anticipated. We expect that these patients provide the largest signal with lung protective interventions in relation to lung healthy patients.\n\nExclusion Criteria:\n\n* Previous surgery on the heart or lungs\n* Previous thoracic irradiation\n* Preoperative heart failure (ejection fraction below 20%).\n* Surgical demanding mitral regurgitation\n* Unstable patients (heart rate above 100 and systolic blood pressure below 100 mmHg)\n* Intubated patients\n* Patients with an ongoing preoperative treatment with antibiotics for suspected pneumonia.\n* Patients with renal insufficiency requiring hemodialysis\n* Pregnant and lactating'}, 'identificationModule': {'nctId': 'NCT01614951', 'briefTitle': 'The Pulmonary Protection Trial', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions', 'orgStudyIdInfo': {'id': '4141'}, 'secondaryIdInfos': [{'id': '2011-006290-25', 'type': 'EUDRACT_NUMBER'}, {'id': '4141', 'type': 'OTHER', 'domain': 'EudraCT Protocol kode'}, {'id': 'H-1-2012-0 24', 'type': 'OTHER', 'domain': 'The Danish Scientific Ethical Committee protocol code'}, {'id': '2007-58-0015.', 'type': 'OTHER', 'domain': 'The Danish Data Protection Agency journal number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary perfusion', 'interventionNames': ['Procedure: Perfusion of the lungs']}, {'type': 'EXPERIMENTAL', 'label': 'Pulmoplegia', 'interventionNames': ['Drug: HTK Custodiol']}, {'type': 'OTHER', 'label': 'Control group', 'interventionNames': ['Other: Standard ECC']}], 'interventions': [{'name': 'Perfusion of the lungs', 'type': 'PROCEDURE', 'description': 'Pulmonary perfusion with oxygenated blood during ECC.', 'armGroupLabels': ['Pulmonary perfusion']}, {'name': 'HTK Custodiol', 'type': 'DRUG', 'description': 'Pulmoplegia before ECC.', 'armGroupLabels': ['Pulmoplegia']}, {'name': 'Standard ECC', 'type': 'OTHER', 'description': 'ECC after standard procedure', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen N', 'country': 'Denmark', 'facility': 'Rigshospitalet'}], 'overallOfficials': [{'name': 'Daniel A. Steinbrüchel, prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Thoracic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundbeck Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr. med.', 'investigatorFullName': 'Daniel Steinbruchel', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}