Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-04-05 @ 1:02 AM
Study NCT ID:
NCT03271268
Status:
UNKNOWN
Last Update Posted:
2017-09-07
First Post:
2017-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D004487', 'term': 'Edema'}, {'id': 'D011654', 'term': 'Pulmonary Edema'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum bank : 1 sample (5 ml of blood): on admission and from day 1 to day 7 of admission.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2019-04-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-04', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung edema', 'timeFrame': 'During the first 7 days of admission', 'description': 'Extravascular lung water (EVLW) \\> 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)'}], 'secondaryOutcomes': [{'measure': 'Hypoxemia', 'timeFrame': 'During the first 7 days of admission for mechanically-ventilated patients', 'description': 'PaO2/FiO2 ratio of \\<200'}, {'measure': 'Hypercapnia', 'timeFrame': 'During the first 7 days of admission for mechanically-ventilated patients', 'description': 'PaCO2\\> 45 mmHg'}, {'measure': 'Corrected minute ventilation > 10L/min', 'timeFrame': 'During the first 7 days of admission for mechanically-ventilated patients', 'description': 'Minute ventilation × partial \\[Paco2\\]/40) \\> 10L/min'}, {'measure': 'Multiple organ dysfunction syndrome (MODS)', 'timeFrame': 'During the first 7 days of admission', 'description': 'Sequential Organ Failure Assessment score (SOFA) ≥ 8'}, {'measure': '28-day mortality', 'timeFrame': '28 days'}, {'measure': '90-day mortality', 'timeFrame': '90 days'}, {'measure': 'Length of stay in the ICU', 'timeFrame': 'until 90 days of hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular filling', 'Fluid overload', 'Biomarkers', 'Lung edema'], 'conditions': ['Burns']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=Soluble+CD146%2C+a+new+endothelial+biomarker+of+acutely+decompensated+heart+failure', 'label': 'Soluble CD146, a new endothelial biomarker of acutely decompensated heart failure'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/23425748', 'label': 'Natriuretic peptide type B in burn intensive care'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=Plasma+Levels+of+Soluble+CD146+Reflect+the+Severity+of+Pulmonary+Congestion+Better+Than+Brain+Natriuretic+Peptide+in+Acute+Coronary+Syndrome', 'label': 'Plasma Levels of Soluble CD146 Reflect the Severity of Pulmonary Congestion Better Than Brain Natriuretic Peptide in Acute Coronary Syndrome'}]}, 'descriptionModule': {'briefSummary': 'Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema.\n\nThe peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia .\n\nOur hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severely ill burn patients admitted to a tertiary referral burn center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubated mechanically-ventilated patients within the first 24 hours of admission\n* And/or patients with total body surface area (TBSA) burn-injured \\>20 %\n* And/or patients with at least 10% full-thickness burns\n* And/or receiving vasopressors within the first 24 hours of admission\n* And monitored by a PiCCO system (PiCCO-2 Pulsion Medical Systems AG, Munich, Germany)\n\nExclusion Criteria:\n\n* Admission delay to ICU \\> 24 hours post burn\n* Age less than 18 years\n* Pregnancy\n* Chronic renal impairment with a baseline eGFR \\< 15 ml/min\n* Patients with chemical or electrical burns\n* Coexisting non-burn trauma\n* Patients moribund on admission or dead within 72 h from admission\n* Patients with do-not-resuscitate orders'}, 'identificationModule': {'nctId': 'NCT03271268', 'acronym': 'CAROLE', 'briefTitle': 'Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients', 'organization': {'class': 'OTHER', 'fullName': 'Saint-Louis Hospital, Paris, France'}, 'officialTitle': 'The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients', 'orgStudyIdInfo': {'id': 'StLouisFrance'}}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sabri Soussi, MD', 'role': 'CONTACT', 'email': 'sabri.soussi@gmail.com', 'phone': '0613064542', 'phoneExt': '+33'}, {'name': 'Matthieu Legrand, MD, PhD', 'role': 'CONTACT', 'email': 'matthieu.m.legrand@gmail.com', 'phone': '0685104235', 'phoneExt': '+33'}], 'facility': 'Sabri SOUSSI', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Sabri Soussi, MD', 'role': 'CONTACT', 'email': 'sabri.soussi@gmail.com', 'phone': '0613064542', 'phoneExt': '+33'}, {'name': 'Matthieu Legrand, MD, PhD', 'role': 'CONTACT', 'email': 'matthieu.m.legrand@gmail.com', 'phone': '0685104235', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Sabri Soussi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint-Louis Hospital, Paris, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint-Louis Hospital, Paris, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sabri SOUSSI', 'investigatorAffiliation': 'Saint-Louis Hospital, Paris, France'}}}}