Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT04376905
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extra Vascular Lung Water and Pulmonary Permeability in Critically Ill Patients With SARS-CoV-2 (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Extra Vascular Lung Water', 'timeFrame': 'Since intubation at day 0 and measured repetitively by 6 hours until day 3', 'description': 'EVLW (ml/kg) measured by a PiCCO device using TPTD thermodilution'}], 'secondaryOutcomes': [{'measure': 'Changes of Pulmonary Vascular Permeability Index', 'timeFrame': 'Since intubation at day 0 and measured repetitively by 6 hours until day 3', 'description': 'PVPI measured by a PiCCO device using TPTDventilation, duration of ICU length of stay, ICU mortality'}, {'measure': 'Changes of pulmonary compliance', 'timeFrame': 'Since intubation at day 0 and measured repetitively by 6 hours until day 3', 'description': 'Changes of pulmonary compliance (ml/mmHg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'ICU', 'Transpulmonary thermodilution', 'Extravascular lung water', 'Pulmonary Vascular Permeability Index'], 'conditions': ['COVID-19', 'Pneumonia', 'Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': "Acute respiratory distress syndrome (ARDS) is a syndromic definition of an acute lung injury with alteration of biomechanics (lower respiratory system compliance) mostly associated with increased lesional edema. Increase in Pulmonary Vascular Permeability Index (PVPI) accompanied with accumulation of excess Extravascular Lung Water (EVLW) is the hallmark of ARDS. In routine clinical practice, the investigators measure the EVLW and PVPI in ARDS patients, as suggested by expert's recommendations, using a transpulmonary thermodilution (TPTD) technique.\n\nSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly recognized illness that has spread rapidly throughout Wuhan (Hubei province) to other provinces in China and around the world. Most critically ill patients with SARS-CoV-2 will present the criteria for the definition of ARDS. However, many of these patients have a particular form of ARDS with severe hypoxemia often associated with near normal respiratory system compliance. This combination is almost never seen in severe ARDS. Thus other mechanisms (including probably vascular mechanisms), that are still poorly described, have to be involved in SARS-CoV-2.\n\nEVLW and PVPI have never been assessed in SARS-CoV-2 mechanically ventilated patients. The aim of this study is to evaluate these two parameters in order to best characterize and understand the mechanisms related to SARS-CoV-2.\n\nBased on observation of several cases in intensive care units (ICU), the investigators hypothesize that there are following different SARS-CoV-2 patterns:\n\n1. Nearly normal compliance, low lung recruitability, normal EVLW and low PVPI.\n2. Low compliance due to increased edema, high lung recruitability, high EVLW and high PVPI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 critically ill patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* COVID-19 critically ill patients\n* Invasive mechanical ventilation\n\nExclusion criteria:\n\n* Age under 18\n* Pregnancy\n* Legally protected adults\n* Contra-indication of using PiCCO device: jugular venous thrombosis, or severe chronic femoral/iliac artery occlusive disease'}, 'identificationModule': {'nctId': 'NCT04376905', 'acronym': 'PiCCOVID', 'briefTitle': 'Extra Vascular Lung Water and Pulmonary Permeability in Critically Ill Patients With SARS-CoV-2 (COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Assessment of Extra Vascular Lung Water and Pulmonary Permeability by Transpulmonary Thermodilution in Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)', 'orgStudyIdInfo': {'id': 'RECHMPL20_0193'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Kada KLOUCHE, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UH Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}