Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT04388267
Status:
UNKNOWN
Last Update Posted:
2020-05-18
First Post:
2020-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D065906', 'term': 'Hyperlactatemia'}, {'id': 'D009846', 'term': 'Oliguria'}, {'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D001019', 'term': 'Aortic Rupture'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D017542', 'term': 'Aneurysm, Ruptured'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-14', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of arterial elastance', 'timeFrame': '60 minutes', 'description': 'Absolute and percentage of change in arterial elastance during the study period'}, {'measure': 'Evolution of Stroke Volume (SV)', 'timeFrame': '60 minutes', 'description': 'Absolute and percentage of change in stroke volume during the study period'}], 'secondaryOutcomes': [{'measure': 'Evolution of Dicrotic Pressure (DP) value during a fluid challenge', 'timeFrame': '60 minutes', 'description': 'Absolute and percentage of change in dicrotic pressure during the study period'}, {'measure': 'Predictive factors of an increase or a decrease in the arterial elastance value', 'timeFrame': '60 minutes', 'description': 'Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the arterial elastance\n\n* epidemiological and clinical: age, BMI, gender, SAPS II, SOFA, Charlson comorbidity index, chronic diseases, etiology of the septic shock, acute kidney injury\n* therapeutical: chronic treatments, vasoactive and sedative drugs, epidural analgesia, mechanical ventilation (VT, RR, PEEP)\n* surgery: type of surgery (open or endovascular), indication, timing.\n* indication for fluid loading: hypotension, oliguria, hyperlactatemia \\> 2mmol/L, mottling'}, {'measure': 'Predictive factors of an increase or a decrease of the dicrotic pressure value', 'timeFrame': '60 minutes', 'description': 'Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the dicrotic pressure'}, {'measure': 'Evolution of norepinephrine dose: before and 60 minutes after fluid challenge', 'timeFrame': '60 minutes', 'description': 'Norepinephrine dose expressed in micrograms per kilogram per minute (μg/kg/min)'}, {'measure': 'All-cause mortality', 'timeFrame': '30 days', 'description': '30 days all-cause mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mostcare', 'Vascular surgery', 'Arterial Elastance', 'Dicrotic pressure', 'Fluid loading', 'Pressure Recording Analytical Method', 'Hemodynamic monitoring', 'Pulse contour analysis'], 'conditions': ['Shock, Septic', 'Hyperlactatemia', 'Oliguria', 'Aortic Aneurysm, Abdominal', 'Aortic Aneurysm, Ruptured', 'Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '28012725', 'type': 'BACKGROUND', 'citation': 'Romagnoli S, Franchi F, Ricci Z, Scolletta S, Payen D. The Pressure Recording Analytical Method (PRAM): Technical Concepts and Literature Review. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1460-1470. doi: 10.1053/j.jvca.2016.09.004. Epub 2016 Sep 14. No abstract available.'}, {'pmid': '24055563', 'type': 'BACKGROUND', 'citation': 'Romagnoli S, Ricci Z, Romano SM, Dimizio F, Bonicolini E, Quattrone D, De Gaudio R. FloTrac/Vigileo(TM) (third generation) and MostCare((R))/PRAM versus echocardiography for cardiac output estimation in vascular surgery. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1114-21. doi: 10.1053/j.jvca.2013.04.017. Epub 2013 Sep 19.'}, {'pmid': '24398442', 'type': 'BACKGROUND', 'citation': 'Gopal S, Do T, Pooni JS, Martinelli G. Validation of cardiac output studies from the Mostcare compared to a pulmonary artery catheter in septic patients. Minerva Anestesiol. 2014 Mar;80(3):314-23. Epub 2014 Jan 8.'}, {'pmid': '28722695', 'type': 'BACKGROUND', 'citation': 'Messina A, Romano SM, Bonicolini E, Colombo D, Cammarota G, Chiostri M, Della Corte F, Navalesi P, Payen D, Romagnoli S. Cardiac cycle efficiency and dicrotic pressure variations: new parameters for fluid therapy: An observational study. Eur J Anaesthesiol. 2017 Nov;34(11):755-763. doi: 10.1097/EJA.0000000000000661.'}, {'pmid': '26077088', 'type': 'BACKGROUND', 'citation': 'Monge Garcia MI, Guijo Gonzalez P, Gracia Romero M, Gil Cano A, Oscier C, Rhodes A, Grounds RM, Cecconi M. Effects of fluid administration on arterial load in septic shock patients. Intensive Care Med. 2015 Jul;41(7):1247-55. doi: 10.1007/s00134-015-3898-7. Epub 2015 Jun 11.'}, {'pmid': '28101605', 'type': 'BACKGROUND', 'citation': 'Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.'}, {'pmid': '18617626', 'type': 'BACKGROUND', 'citation': 'Chantler PD, Lakatta EG, Najjar SS. Arterial-ventricular coupling: mechanistic insights into cardiovascular performance at rest and during exercise. J Appl Physiol (1985). 2008 Oct;105(4):1342-51. doi: 10.1152/japplphysiol.90600.2008. Epub 2008 Jul 10.'}, {'pmid': '6638199', 'type': 'BACKGROUND', 'citation': 'Sunagawa K, Maughan WL, Burkhoff D, Sagawa K. Left ventricular interaction with arterial load studied in isolated canine ventricle. Am J Physiol. 1983 Nov;245(5 Pt 1):H773-80. doi: 10.1152/ajpheart.1983.245.5.H773.'}, {'pmid': '23510336', 'type': 'BACKGROUND', 'citation': 'Guarracino F, Baldassarri R, Pinsky MR. Ventriculo-arterial decoupling in acutely altered hemodynamic states. Crit Care. 2013 Mar 19;17(2):213. doi: 10.1186/cc12522. No abstract available.'}, {'pmid': '5308142', 'type': 'BACKGROUND', 'citation': 'Suga H. Time course of left ventricular pressure-volume relationship under various enddiastolic volume. Jpn Heart J. 1969 Nov;10(6):509-15. doi: 10.1536/ihj.10.509. No abstract available.'}, {'pmid': '24762124', 'type': 'BACKGROUND', 'citation': 'Guarracino F, Ferro B, Morelli A, Bertini P, Baldassarri R, Pinsky MR. Ventriculoarterial decoupling in human septic shock. Crit Care. 2014 Apr 24;18(2):R80. doi: 10.1186/cc13842.'}, {'pmid': '27101380', 'type': 'BACKGROUND', 'citation': "Morelli A, Singer M, Ranieri VM, D'Egidio A, Mascia L, Orecchioni A, Piscioneri F, Guarracino F, Greco E, Peruzzi M, Biondi-Zoccai G, Frati G, Romano SM. Heart rate reduction with esmolol is associated with improved arterial elastance in patients with septic shock: a prospective observational study. Intensive Care Med. 2016 Oct;42(10):1528-1534. doi: 10.1007/s00134-016-4351-2. Epub 2016 Apr 21."}, {'pmid': '27613430', 'type': 'BACKGROUND', 'citation': 'Walley KR. Left ventricular function: time-varying elastance and left ventricular aortic coupling. Crit Care. 2016 Sep 10;20(1):270. doi: 10.1186/s13054-016-1439-6.'}, {'pmid': '29019850', 'type': 'BACKGROUND', 'citation': 'Guinot PG, Longrois D, Kamel S, Lorne E, Dupont H. Ventriculo-Arterial Coupling Analysis Predicts the Hemodynamic Response to Norepinephrine in Hypotensive Postoperative Patients: A Prospective Observational Study. Crit Care Med. 2018 Jan;46(1):e17-e25. doi: 10.1097/CCM.0000000000002772.'}]}, 'descriptionModule': {'briefSummary': 'The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy), provides new hemodynamic parameters of the cardiovascular system. The PRAM method is a noncalibrated pulse contour method which requires only an arterial line (radial or femoral). This method has been validated in various clinical conditions. Among the collected parameters, some are well known and used daily care in Intensive Care Unit (ICU), i.e. cardiac output (CO), arterial pressure, heart rate, stroke volume (SV). Others such as arterial elastance (Ea) or dicrotic pressure are more recent and merit further investigation to determine their interest in clinical practice. To date, it is rarely used to adapt therapies, mostly because of a lack of knowledge regarding the evolution of these parameters.\n\nThe aim of this study is to analyze the relationship between the evolution of Arterial Elastance and fluid responsiveness after a 250 mL fluid challenge of crystalloids in 5 minutes in patients with either septic shock or in the postoperative course of a major vascular surgery.\n\nPatients will be considered fluid responders if an increase \\>10% of the stroke volume is observed .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is a mix of septic shock and patients who underwent elective or emergent major vascular surgery surgery (aortic mostly) requiring a fluid challenge because of hypotension and/or oliguria and/or mottling and/or hyperlactatemia\\>2mmol/L. All patients will be hospitalized in the surgical intensive care unit (ICU) of the University Hospital of Nancy Brabois, France.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 18 years\n* Septic shock (according to Sepsis-3 definition) or patients who underwent elective or emergent abdominal aortic surgery\n* Invasive blood pressure (radial or femoral) and Mostcare monitoring\n* Stroke volume between 20 and 50 mL/beat on the Mostcare system\n* Indication for a fluid challenge: hypotension (Mean arterial pressure under 65mmHg) or oliguria (urine flow rate \\< 0,5mL/kg/h for more than 12h), mottling, hyperlactatemia \\> 2 mmol/l\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Cardiac arrhythmia\n* Arterial wave form distortion\n* Inappropriate identification of the dicrotic notch for any reason\n* Refuse to consent to the study'}, 'identificationModule': {'nctId': 'NCT04388267', 'acronym': 'RELASTANCE', 'briefTitle': 'Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Comparative Study on the Relationship Between Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or in the Postoperative Course of Aortic Surgery', 'orgStudyIdInfo': {'id': 'PSS2018/RELASTANCE-GUERCI/YB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Septic shock', 'description': 'Patients with septic shock, according to the Sepsis 3 definition, regardless of the origin', 'interventionNames': ['Drug: Fluid challenge']}, {'label': 'Major vascular surgery', 'description': 'Patients who underwent elective or emergent major vascular surgery abdominal aortic surgery (open or endovascular surgery)', 'interventionNames': ['Drug: Fluid challenge']}], 'interventions': [{'name': 'Fluid challenge', 'type': 'DRUG', 'description': 'All patients who met the inclusion criteria will receive a standardised bolus of 250 ml of crystalloid in 5 minutes administered by hand with a 50 ml syringe.\n\nDuring the study period, hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected for 20 minutes prior to the intervention (fluid challenge), during the fluid challenge and 25 minutes after completion.\n\nThe total duration of the intervention (fluid loading) is 5 min. The total duration of hemodynamic parameters recording is 60 min.', 'armGroupLabels': ['Major vascular surgery', 'Septic shock']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Phillipe Guerci, MD', 'role': 'CONTACT', 'email': 'p.guerci@chru-nancy.fr', 'phone': '+33 3 83 15 79 95'}], 'facility': 'CHRU', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Philippe Guerci, MD', 'role': 'CONTACT', 'email': 'p.guerci@chru-nancy.fr', 'phone': '+33 3 83 15 79 95'}, {'name': 'Nicolas Dellestable', 'role': 'CONTACT', 'email': 'nico.dellestable@hotmail.fr', 'phone': '+33 6 18 85 05 26'}], 'overallOfficials': [{'name': 'Philippe Guerci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}