Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT03366857
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2017-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Supplemental Oxygen on Perioperative BNP Concentration in Cardiac Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants don´t know the randomized oxygen concentration. The postoperative follow up will be performed by a blinded research fellow.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2017-12-02', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Postoperative Brain Natriuretic Peptide (BNP) concentration compared to preoperative baseline measurement during hospitalization', 'timeFrame': 'Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 and within 72 hours before hospital discharge', 'description': 'Perioperative BNP Concentration'}], 'secondaryOutcomes': [{'measure': 'Redox Status - sORP (static oxidation-reduction potential), cORP (capacity oxidation-reduction potential)', 'timeFrame': 'Preoperative, 2 hours after induction of anesthesia, postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3 and within 72 hours before hospital discharge', 'description': 'Measurement of the Redox status using the RedoxSYS(R) system'}, {'measure': 'Copeptin', 'timeFrame': 'Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3', 'description': 'Perioperative plasma Copeptin concentration'}, {'measure': 'MINS (myocardial ischemia after noncardiac surgery)', 'timeFrame': 'Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3', 'description': 'Troponin T (TnT) measurement'}, {'measure': 'vWF (von Willebrand factor) Antigen', 'timeFrame': 'Preoperative, Postoperative (within 2 hours after end of surgery), Postoperative day 1 and 3', 'description': 'Effect of supplemental oxygen on inflammatory response using von Willebrand factor antigen'}, {'measure': 'Fluid measurement', 'timeFrame': 'Intraoperative', 'description': 'Due to the peripheral vasoconstriction of hyperoxia we measure the needed fluid for hemodynamic stability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Supplemental Oxygen', 'Brain Natriuretic Peptide', 'Cardiac Risk Patients', 'Perioperative']}, 'referencesModule': {'references': [{'pmid': '19826023', 'type': 'BACKGROUND', 'citation': 'Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.'}, {'pmid': '10639541', 'type': 'BACKGROUND', 'citation': 'Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.'}, {'pmid': '16806535', 'type': 'BACKGROUND', 'citation': 'Shigemitsu M, Nishio K, Kusuyama T, Itoh S, Konno N, Katagiri T. Nocturnal oxygen therapy prevents progress of congestive heart failure with central sleep apnea. Int J Cardiol. 2007 Feb 14;115(3):354-60. doi: 10.1016/j.ijcard.2006.03.018. Epub 2006 Jun 23.'}, {'pmid': '23528538', 'type': 'BACKGROUND', 'citation': 'Rodseth RN, Biccard BM, Chu R, Lurati Buse GA, Thabane L, Bakhai A, Bolliger D, Cagini L, Cahill TJ, Cardinale D, Chong CP, Cnotliwy M, Di Somma S, Fahrner R, Lim WK, Mahla E, Le Manach Y, Manikandan R, Pyun WB, Rajagopalan S, Radovic M, Schutt RC, Sessler DI, Suttie S, Vanniyasingam T, Waliszek M, Devereaux PJ. Postoperative B-type natriuretic peptide for prediction of major cardiac events in patients undergoing noncardiac surgery: systematic review and individual patient meta-analysis. Anesthesiology. 2013 Aug;119(2):270-83. doi: 10.1097/ALN.0b013e31829083f1.'}, {'pmid': '37324125', 'type': 'DERIVED', 'citation': 'Reiterer C, Fleischmann E, Kabon B, Taschner A, Kurz A, Adamowitsch N, von Sonnenburg MF, Fraunschiel M, Graf A. Hemodynamic effects of intraoperative 30% versus 80% oxygen concentrations: an exploratory analysis. Front Med (Lausanne). 2023 May 30;10:1200223. doi: 10.3389/fmed.2023.1200223. eCollection 2023.'}, {'pmid': '34856530', 'type': 'DERIVED', 'citation': 'Reiterer C, Fleischmann E, Taschner A, Adamowitsch N, von Sonnenburg MF, Graf A, Fraunschiel M, Starlinger P, Goschin J, Kabon B. Perioperative supplemental oxygen and oxidative stress in patients undergoing moderate- to high-risk major abdominal surgery - A subanalysis of randomized clinical trial. J Clin Anesth. 2022 May;77:110614. doi: 10.1016/j.jclinane.2021.110614. Epub 2021 Nov 29.'}, {'pmid': '34087659', 'type': 'DERIVED', 'citation': 'Reiterer C, Kabon B, Taschner A, Falkner von Sonnenburg M, Graf A, Adamowitsch N, Starlinger P, Goshin J, Fraunschiel M, Fleischmann E. Perioperative supplemental oxygen and NT-proBNP concentrations after major abdominal surgery - A prospective randomized clinical trial. J Clin Anesth. 2021 Oct;73:110379. doi: 10.1016/j.jclinane.2021.110379. Epub 2021 Jun 1.'}, {'pmid': '32398119', 'type': 'DERIVED', 'citation': 'Reiterer C, Kabon B, von Sonnenburg MF, Starlinger P, Taschner A, Zotti O, Goshin J, Drlicek G, Fleischmann E. The effect of supplemental oxygen on perioperative brain natriuretic peptide concentration in cardiac risk patients - a protocol for a prosprective randomized clinical trial. Trials. 2020 May 12;21(1):400. doi: 10.1186/s13063-020-04336-9.'}]}, 'descriptionModule': {'briefSummary': 'The effect of supplemental oxygen on surgical site infections was already investigated in several studies before. Although, oxygen is one of the most used medical therapy in hospitalized patients, the influence on the cardiovascular system is still unknown. Available data indicate beneficial effects of supplemental oxygen on cardiovascular function. Because, no evidence exists concerning the perioperative period, it is our objective to investigate supplemental oxygen in cardiac risk patients undergoing major abdominal surgery. Due to the significant reduction of BNP by inhibiting sympathetic nerve activity we hypothesize that supplemental oxygen have beneficial effects in perioperative BNP release in cardiac risk patients undergoing major abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients over 45 years on age, which fulfill 1 or more of the following 4 criteria undergoing non-cardiac surgery:\n\n1. History of coronary artery disease\n2. History of peripheral arterial disease\n3. History of stroke OR\n4. Any of 3 of 7 A) Age ≥ 70 years B) Undergoing major surgery C) History of congestive heart failure D) History of transient ischemic attack E) Diabetes and currently taking an oral hypoglycemic agent or insulin F) History of Hypertension\n\nFurther inclusion criteria are:\n\n1. Written informed consent\n2. Elective major abdominal open surgery or laparoscopically assisted procedures scheduled to take over two hours done under general anesthesia (colorectal, urology, gynecology, liver and pancreatic surgery)\n\nExclusion Criteria:\n\n1. Symptoms of infection or sepsis\n2. Preoperative inotropic therapy\n3. Patients under ICU treatment\n4. Oxygen dependent patients\n5. History of severe heart failure and/or ejection fraction \\< 30%'}, 'identificationModule': {'nctId': 'NCT03366857', 'briefTitle': 'Effect of Supplemental Oxygen on Perioperative BNP Concentration in Cardiac Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Effect of Supplemental Oxygen on Perioperative Brain Natriuretic Peptide Concentration in Cardiac Risk Patients - A Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '1744/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '30%', 'description': 'Participants allocated to these groups will receive a FiO2 of 0.3 during the operation and for two hours postoperatively.', 'interventionNames': ['Drug: Oxygen 30 %']}, {'type': 'ACTIVE_COMPARATOR', 'label': '80%', 'description': 'Participants allocated to these groups will receive a FiO2 of 0.8 during the operation and for two hours postoperatively.', 'interventionNames': ['Drug: Oxygen 80 %']}], 'interventions': [{'name': 'Oxygen 30 %', 'type': 'DRUG', 'description': 'The oxygen concentration will be set at 30%.', 'armGroupLabels': ['30%']}, {'name': 'Oxygen 80 %', 'type': 'DRUG', 'description': 'The oxygen concentration will be set at 80%.', 'armGroupLabels': ['80%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Edith Fleischmann, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. univ.', 'investigatorFullName': 'Christian Reiterer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}