Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT01806467
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
2013-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a New Method to Measure Cardiac Output: Comparison With Thermodilution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-06', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blant-Altman test and coefficient of error of Cardiac Output measured with PRAM towards that measured with thermodilution', 'timeFrame': 'Study Period: 9 months', 'description': 'Agreement between Cardiac Output measured with PRAM and cardiac output measured with thermodilution (both pulmonary and transpulmonary thermodilution) was determined by the Bland-Altman method. The precision of the measurements was given by the limits of agreement (LoA) (±1.96SD) of the mean difference of the methods compared. Upper and lower LoA were calculated as the bias ± 1.96SD. The percentage error was calculated as the LoA of the bias divided by the mean CO from two methods compared. Thirty per cent was considered an a priori criterion of interchangeability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemodynamic Instability']}, 'descriptionModule': {'briefSummary': 'Many mini-invasive devices to monitor cardiac output (CO) have been introduced and among them the Pressure Recording Analytical Method (PRAM). The aim of this study is to assess the agreement of PRAM with the intermittent transpulmonary thermodilution (ThD) and continuous pulmonary ThD in measuring CO in hemodynamically unstable patients.', 'detailedDescription': 'Hemodynamic monitoring is important in critically ill patients. It is often used to assess a cardiovascular derangements, to help diagnosing the causes and to monitor the response to therapy.\n\nPulmonary thermodilution (ThD) is still considered the gold standard reference method for cardiac output (CO) measurement \\[1\\]. Its invasiveness, however, often limits or delays its application \\[2, 3\\]. In the last decades new less invasive hemodynamic monitoring systems have been developed. The majority of such new devices allows for continuous monitoring of CO and other hemodynamic variables \\[4\\].\n\nAmong the various less invasive techniques, the PiCCO (Pulse-induced Contour Cardiac Output) relies on the concept of the "pulse contour methodology" for providing beat-to-beat CO assessment. This method needs transpulmonary ThD calibration. This is a well validated dilution technique \\[5\\]. Another minimally invasive system is the Pressure Recording Analytical Method (PRAM). Unlike other systems with pulse contour analysis, the PRAM does not need external or internal calibration factors since it analyzes the pressure waveform at a frequency of 1000 Hz and computes the patient\'s cardiovascular system impedance using a mathematical algorithm based on the physical theory of perturbations. It only requires a connection to a femoral or radial artery catheter for the acquisition and analysis of the arterial pressure traces \\[6\\]. This new method has been validated under different experimental and clinical settings \\[6-9\\]. Limited data are available under conditions of hemodynamic instability \\[10-12\\]. So far, its accuracy and reliability in assessing CO in hemodynamically unstable patients needs yet to be clarified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hemodynamic instability', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHemodynamic instability in:\n\n* septic shock\n* pneumonia\n* polytrauma\n* chronic obstructive pulmonary disease\n* heart failure\n* post operative cardiosurgical patients\n\nExclusion Criteria:\n\n* Atrial fibrillation\n* Pacemaker or implantable cardiac defibrillator\n* Aortic or mitral valve disease\n* Intra-aortic balloon pump'}, 'identificationModule': {'nctId': 'NCT01806467', 'briefTitle': 'Validation of a New Method to Measure Cardiac Output: Comparison With Thermodilution', 'organization': {'class': 'OTHER', 'fullName': 'Università Politecnica delle Marche'}, 'officialTitle': 'Continuous Thermodilution, Transpulmonary Thermodilution and Pressure Recording Analytical Method for Cardiac Output Measurement During Hemodynamic Instability: a Prospective Clinical Study', 'orgStudyIdInfo': {'id': '210107'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'critically ill patients', 'description': 'patients admitted to the medical-surgical ICU'}, {'label': 'post-cardiac surgical patients', 'description': 'patients admitted to the post-cardiac surgical ICU'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60126', 'city': 'Ancona', 'state': 'Ancona', 'country': 'Italy', 'facility': 'AOU Ospedali Riuniti Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}], 'overallOfficials': [{'name': 'Abele Donati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPollitecnicaDM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Politecnica delle Marche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Abele Donati, MD', 'investigatorAffiliation': 'Università Politecnica delle Marche'}}}}