Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-01-06 @ 1:27 AM
Study NCT ID:
NCT04628195
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2020-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Performance in Mechanically Ventilated COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-12', 'studyFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with left ventricle dysfunction (hypokinetic)', 'timeFrame': '3 month', 'description': 'Hypokinetic left ventricle function (left ventricle ejection fraction \\<45%)'}, {'measure': 'Percentage of patients with acute cor pulmonale', 'timeFrame': '3 month', 'description': 'Acute cor pulmonale was defined as a dilated right ventricle (right ventricle end-diastolic area/left ventricle end-diastolic area ratio \\>0.6) associated with the presence of paradoxical septum motion'}], 'secondaryOutcomes': [{'measure': 'Differences in respiratory system compliance between patients with and without acute cor pulmonale', 'timeFrame': 'Within the first 24 hours of mechanical ventilation.', 'description': 'Respiratory system compliance is defined as the change in lung volume (Tidal volume, ml) produced by a unit change in pulmonary pressure (driving pressure, cmH2O). The reported value of respiratory system compliance will be reported in ml/cmH2O.'}, {'measure': 'Differences in partial arterial pressure of carbon dioxide (PCO2) between patients with and without acute cor pulmonale', 'timeFrame': 'Within the first 24 hours of mechanical ventilation.', 'description': 'Partial arterial pressure of carbon dioxide will be reported in mmHg.'}, {'measure': 'Differences in PaO2/FiO2 ratio between patients with and without acute cor pulmonale', 'timeFrame': 'Within the first 24 hours of mechanical ventilation.', 'description': 'PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction). The reported value is a positive integer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Care Echocardiography', 'Cardiac Function', 'Acute Cor Pulmonale', 'COVID-19', 'Mechanical Ventilation', 'SARS-CoV-2'], 'conditions': ['Covid19', 'Acute Cor Pulmonale', 'Cardiac Failure']}, 'referencesModule': {'references': [{'pmid': '32211816', 'type': 'BACKGROUND', 'citation': 'Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.'}, {'pmid': '32291207', 'type': 'BACKGROUND', 'citation': 'Deng Q, Hu B, Zhang Y, Wang H, Zhou X, Hu W, Cheng Y, Yan J, Ping H, Zhou Q. Suspected myocardial injury in patients with COVID-19: Evidence from front-line clinical observation in Wuhan, China. Int J Cardiol. 2020 Jul 15;311:116-121. doi: 10.1016/j.ijcard.2020.03.087. Epub 2020 Apr 8.'}, {'pmid': '32537662', 'type': 'BACKGROUND', 'citation': 'Rath D, Petersen-Uribe A, Avdiu A, Witzel K, Jaeger P, Zdanyte M, Heinzmann D, Tavlaki E, Muller K, Gawaz MP. Impaired cardiac function is associated with mortality in patients with acute COVID-19 infection. Clin Res Cardiol. 2020 Dec;109(12):1491-1499. doi: 10.1007/s00392-020-01683-0. Epub 2020 Jun 14.'}, {'pmid': '32219357', 'type': 'BACKGROUND', 'citation': 'Inciardi RM, Lupi L, Zaccone G, Italia L, Raffo M, Tomasoni D, Cani DS, Cerini M, Farina D, Gavazzi E, Maroldi R, Adamo M, Ammirati E, Sinagra G, Lombardi CM, Metra M. Cardiac Involvement in a Patient With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):819-824. doi: 10.1001/jamacardio.2020.1096.'}, {'pmid': '32277408', 'type': 'BACKGROUND', 'citation': 'Zeng JH, Liu YX, Yuan J, Wang FX, Wu WB, Li JX, Wang LF, Gao H, Wang Y, Dong CF, Li YJ, Xie XJ, Feng C, Liu L. First case of COVID-19 complicated with fulminant myocarditis: a case report and insights. Infection. 2020 Oct;48(5):773-777. doi: 10.1007/s15010-020-01424-5. Epub 2020 Apr 10.'}, {'pmid': '32469253', 'type': 'BACKGROUND', 'citation': 'Szekely Y, Lichter Y, Taieb P, Banai A, Hochstadt A, Merdler I, Gal Oz A, Rothschild E, Baruch G, Peri Y, Arbel Y, Topilsky Y. Spectrum of Cardiac Manifestations in COVID-19: A Systematic Echocardiographic Study. Circulation. 2020 Jul 28;142(4):342-353. doi: 10.1161/CIRCULATIONAHA.120.047971. Epub 2020 May 29.'}, {'pmid': '32556199', 'type': 'BACKGROUND', 'citation': 'Dweck MR, Bularga A, Hahn RT, Bing R, Lee KK, Chapman AR, White A, Salvo GD, Sade LE, Pearce K, Newby DE, Popescu BA, Donal E, Cosyns B, Edvardsen T, Mills NL, Haugaa K. Global evaluation of echocardiography in patients with COVID-19. Eur Heart J Cardiovasc Imaging. 2020 Sep 1;21(9):949-958. doi: 10.1093/ehjci/jeaa178.'}, {'pmid': '32474111', 'type': 'BACKGROUND', 'citation': 'Mahmoud-Elsayed HM, Moody WE, Bradlow WM, Khan-Kheil AM, Senior J, Hudsmith LE, Steeds RP. Echocardiographic Findings in Patients With COVID-19 Pneumonia. Can J Cardiol. 2020 Aug;36(8):1203-1207. doi: 10.1016/j.cjca.2020.05.030. Epub 2020 May 28.'}, {'pmid': '32367170', 'type': 'BACKGROUND', 'citation': 'Helms J, Tacquard C, Severac F, Leonard-Lorant I, Ohana M, Delabranche X, Merdji H, Clere-Jehl R, Schenck M, Fagot Gandet F, Fafi-Kremer S, Castelain V, Schneider F, Grunebaum L, Angles-Cano E, Sattler L, Mertes PM, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med. 2020 Jun;46(6):1089-1098. doi: 10.1007/s00134-020-06062-x. Epub 2020 May 4.'}, {'pmid': '32423461', 'type': 'BACKGROUND', 'citation': 'Evrard B, Goudelin M, Montmagnon N, Fedou AL, Lafon T, Vignon P. Cardiovascular phenotypes in ventilated patients with COVID-19 acute respiratory distress syndrome. Crit Care. 2020 May 18;24(1):236. doi: 10.1186/s13054-020-02958-8. No abstract available.'}, {'pmid': '24615559', 'type': 'BACKGROUND', 'citation': 'Expert Round Table on Echocardiography in ICU. International consensus statement on training standards for advanced critical care echocardiography. Intensive Care Med. 2014 May;40(5):654-66. doi: 10.1007/s00134-014-3228-5. Epub 2014 Mar 11. No abstract available.'}, {'pmid': '25559473', 'type': 'BACKGROUND', 'citation': 'Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.'}, {'pmid': '27422899', 'type': 'BACKGROUND', 'citation': 'Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Alexandru Popescu B, Waggoner AD; Houston, Texas; Oslo, Norway; Phoenix, Arizona; Nashville, Tennessee; Hamilton, Ontario, Canada; Uppsala, Sweden; Ghent and Liege, Belgium; Cleveland, Ohio; Novara, Italy; Rochester, Minnesota; Bucharest, Romania; and St. Louis, Missouri. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1321-1360. doi: 10.1093/ehjci/jew082. Epub 2016 Jul 15. No abstract available.'}, {'pmid': '9209605', 'type': 'BACKGROUND', 'citation': 'McLean AS, Needham A, Stewart D, Parkin R. Estimation of cardiac output by noninvasive echocardiographic techniques in the critically ill subject. Anaesth Intensive Care. 1997 Jun;25(3):250-4. doi: 10.1177/0310057X9702500307.'}, {'pmid': '1555616', 'type': 'BACKGROUND', 'citation': 'Alam M, Hoglund C, Thorstrand C, Hellekant C. Haemodynamic significance of the atrioventricular plane displacement in patients with coronary artery disease. Eur Heart J. 1992 Feb;13(2):194-200. doi: 10.1093/oxfordjournals.eurheartj.a060146.'}, {'pmid': '8644649', 'type': 'BACKGROUND', 'citation': 'Gulati VK, Katz WE, Follansbee WP, Gorcsan J 3rd. Mitral annular descent velocity by tissue Doppler echocardiography as an index of global left ventricular function. Am J Cardiol. 1996 May 1;77(11):979-84. doi: 10.1016/s0002-9149(96)00033-1.'}, {'pmid': '8996019', 'type': 'BACKGROUND', 'citation': 'Jardin F, Dubourg O, Bourdarias JP. Echocardiographic pattern of acute cor pulmonale. Chest. 1997 Jan;111(1):209-17. doi: 10.1378/chest.111.1.209. No abstract available.'}, {'pmid': '26650055', 'type': 'BACKGROUND', 'citation': 'Mekontso Dessap A, Boissier F, Charron C, Begot E, Repesse X, Legras A, Brun-Buisson C, Vignon P, Vieillard-Baron A. Acute cor pulmonale during protective ventilation for acute respiratory distress syndrome: prevalence, predictors, and clinical impact. Intensive Care Med. 2016 May;42(5):862-870. doi: 10.1007/s00134-015-4141-2. Epub 2015 Dec 9.'}, {'pmid': '17928992', 'type': 'BACKGROUND', 'citation': 'Lamia B, Teboul JL, Monnet X, Richard C, Chemla D. Relationship between the tricuspid annular plane systolic excursion and right and left ventricular function in critically ill patients. Intensive Care Med. 2007 Dec;33(12):2143-9. doi: 10.1007/s00134-007-0881-y. Epub 2007 Oct 10.'}, {'pmid': '26624559', 'type': 'BACKGROUND', 'citation': 'Edul VS, Ince C, Vazquez AR, Rubatto PN, Espinoza ED, Welsh S, Enrico C, Dubin A. Similar Microcirculatory Alterations in Patients with Normodynamic and Hyperdynamic Septic Shock. Ann Am Thorac Soc. 2016 Feb;13(2):240-7. doi: 10.1513/AnnalsATS.201509-606OC.'}]}, 'descriptionModule': {'briefSummary': 'Although COVID-19 affects primarily the respiratory system, several studies have shown evidence of cardiovascular alterations. Increased troponin levels were observed in a significant proportion of patients and this alteration was associated with higher mortality. In addition, case reports of cardiogenic shock or fulminant myocarditis have been communicated. Likewise, pulmonary embolism (PE), right ventricle dilation, and acute cor pulmonale (ACP) have also been described. Therefore, investigating cardiac function in COVID-19 is highly relevant, particularly in critically ill patients who are usually under sedation and mechanical ventilation, which may further impair cardiovascular function. Thus the objective is to determine the prevalence of left ventricle dysfunction and acute cor pulmonale, and its association with respiratory mechanics, in 100 consecutive critically ill COVID-19 patients, who were assessed with critical care echocardiography (CCE) within the first 24 hours of mechanical ventilation.', 'detailedDescription': "The objective is to determine the prevalence of left ventricle dysfunction and acute cor pulmonale, and its association with respiratory mechanics, in 100 consecutive critically ill COVID-19 patients, who were assessed with critical care echocardiography (CCE) within the first 24 hours of mechanical ventilation.\n\nMaterial and Methods This prospective, multicenter study was conducted between April and June 2020 in the intensive care unit (ICU) of four university-affiliated hospitals of Santiago, Chile. Local ethics committee of each center approved the study and waived the need to provide written informed consent (protocol ID: 200422002). All participating centers have expertise in CCE on clinical grounds.\n\nThe study population Were included systematically all consecutive patients with severe SARS-CoV-2 pneumonia, defined as respiratory failure requiring invasive mechanical ventilation (MV). Patients were included within the first 24 hours of MV. COVID-19 was confirmed by a positive polymerase chain reaction test. The main exclusion criteria were age under 18 years old, severe valvulopathy, poor ultrasound window and do-not-resuscitate status.\n\nDemographic data, Acute Physiology and Chronic Health Evaluation II (APACHE), Sequential Organ Failure Assessment (SOFA) and respiratory system mechanics were recorded.\n\nEchocardiography Transthoracic echocardiography was performed by intensivists trained in echocardiography in according to CCE. Echocardiographic measurements were obtained with a Vivid i echocardiography system (GE Medical Systems, Milwaukee, WI, USA), Philips CX 50 (Philips Healthcare, DA Best, The Netherlands), and Mindray M9 (Bio-Medical Electronics Co., Shenzhen, Chine), as used in each center. All patients were adapted to MV on continuous IV sedation during the echocardiographic assessment. Measurements were acquired at end-expiration and averaged over three consecutive cardiac cycles in according to current recommendations.\n\nStandard echocardiographic views were acquired. Left ventricular systolic function was assessed by the left ventricular ejection fraction (LVEF), as measured with Simpson's modified rule. Based on LVEF patients were categorized in hyperkinetic (LVEF \\>60%), normokinetic (LVEF between 45% and 60%) and hypokinetic (LVEF \\<45%).\n\nCardiac output (CO) was calculated from the left ventricular outflow tract (LVOT) as described by Mclean et al. The diameter of the LVOT was taken from the long parasternal view. Pulsed wave Doppler samples were obtained at the LVOT from the apical view. Doppler velocity curves were manually traced and an average of three measures of velocity time integral (VTI) was calculated. The stroke volume (SV) was calculated as the product of the LVOT area and the VTI. The CO was calculated as the product of the SV and the heart rate obtained during measurement of the aortic VTI. Mitral annular plane systolic excursion (MAPSE) was obtained through an M-mode vector at the level of the mitral annulus at the LV lateral wall. MAPSE was measured in millimeters as described (5). Peak mitral annular myocardial velocity wave (s') was recorded at the level of the mitral annulus at the LV lateral wall with Tissue Doppler Imaging (TDI) as previously described.\n\nLeft ventricular diastolic function was assessed by mitral inflow pulsed wave Doppler, to measure early peak velocity (E) and atrial velocity (A). The early diastolic peak velocity (e') of the lateral mitral annulus was also measured with TDI. From these variables E/A and E/e' ratios were calculated. Diastolic function was categorized as normal, grade I to grade III according to current recommendations.\n\nThe presence of acute cor pulmonale was assessed through the relation between left and right ventricular end-diastolic areas (LVEDA and RVEDA), and by the presence of paradoxical septum motion. LVEDA and RVEDA were measured from the apical four chambers view, and the RVEDA/LVEDA ratio was calculated. Right ventricle (RV) dilatation was defined as RVEDA/LVEDA ratio \\> 0.6, ACP was defined as a dilated RV associated with the presence of paradoxical septum motion. Severe ACP was defined as a severely dilated RV (RVEDA/LVEDA ratio \\>1). Paradoxical septum motion was defined as end-systolic bulging of the interventricular septum toward the left ventricle, while analyzing loops in slow motion. It indirectly assesses RV performance and RV end-diastolic pressures. The paradoxical septum motion was assessed on the four-chamber view. In addition, RV systolic function was assessed by the tricuspid annular plane systolic excursion (TAPSE) obtained through an M-mode vector at the level of the tricuspid annulus.\n\nHemodynamic assessment The hemodynamic profile was based on cardiac index (CI), patients were categorized as hypodynamic (CI\\<2 L⋅min-1⋅m2), normodynamic (CI between 2 and 4 L⋅min-1⋅m2) and hyperdynamic (CI\\>4 L⋅min-1⋅m2). Hemodynamic variables and norepinephrine doses were recorded. Maximum and minimum inferior vena cava (IVC) diameter was measured in M-mode tracing from a longitudinal subcostal view. Fluid responsiveness was assessed by either the respiratory variations of inferior vena cava (IVC), or by the arterial pulse pressure variation (PPV).\n\nThe PiCCO (Continuous Cardiac Output Pulse Index) device was used in thirty patients to assess cardiac output (CO). An average of three consecutive thermodilution measurements was used. Other variables such as global end-diastolic index (GEDI), intrathoracic blood volume index (ITBVI), systemic vascular resistance index (SVRi), cardiac function index (CFi), global ejection fraction (GEF), extravascular lung water index (ELWI), and pulmonary vascular permeability index (PVPI), were recorded.\n\nTissue perfusion was assessed by capillary refill time (CRT) and lactate levels. The peripheral perfusion index (PFI) derived from the photoelectric plethysmography signal of pulse oximetry was also used.\n\nComputer tomography (CT) pulmonary angiography was performed based on the clinical suspicion of PE.\n\nBiomarkers High-sensitive Troponin T and D-Dimer (DD) concentrations were measured simultaneously with echocardiographic assessment. Increases in Troponin T were defined as a value \\>14ng/l.\n\nStatistical Analysis As the study was descriptive sample size but was arbitrarily set at 100 consecutive patients. Normality was tested by Kolmogorov-Smirnov test. The continuous data is presented as mean ± standard deviation or as median and interquartile ranges, depending on the distribution. Comparisons between groups were analyzed by t-test or Wilcoxon rank-sum (WRS) test according to data distribution. Percentages were analyzed using two-proportion z-test. Categorical variables were compared with chi square test. Pearson or Spearman correlation was performed according to data distribution.\n\nIn order to identify independent predictors for mortality, a multivariate regression analysis was carried out including all variables of interest associated with mortality in a univariate analysis (p value \\< 0.05) and adjusting for the other covariates of the logistic regression model. The discrimination of the model was assessed by the area under the receiver operating characteristic (ROC) curve. Statistical analysis was performed with SPSS (version 22.0, IBM SPSS Inc., Chicago, IL, USA). A p value \\< 0.05 was considered statistically significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe SARS-CoV-2 pneumonia, defined as respiratory failure requiring invasive mechanical ventilation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Covid-19 confirmed by a positive polymerase chain reaction test\n* Mechanical ventilation\n\nExclusion Criteria:\n\n* Up to 24 hours on mechanical ventilation\n* Severe valvulopathy\n* Poor ultrasound window\n* Do-not-resuscitate status'}, 'identificationModule': {'nctId': 'NCT04628195', 'briefTitle': 'Cardiac Performance in Mechanically Ventilated COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Cardiac Performance in Mechanically Ventilated Patients With Severe Pneumonia by SARS-CoV-2: Echo-COVID Study', 'orgStudyIdInfo': {'id': '200422002'}}, 'contactsLocationsModule': {'locations': [{'zip': '7550028', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Pontificia Universidad Católica de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinica Alemana de Santiago', 'class': 'OTHER'}, {'name': 'Hospital Barros Luco Trudeau', 'class': 'OTHER'}, {'name': 'University of Chile', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Intensivist', 'investigatorFullName': 'Emilio Valenzuela', 'investigatorAffiliation': 'Pontificia Universidad Catolica de Chile'}}}}