Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-24 @ 5:09 AM
Study NCT ID:
NCT04098094
Status:
UNKNOWN
Last Update Posted:
2022-02-18
First Post:
2019-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2019-09-19', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of hospital stay', 'timeFrame': 'Day 28', 'description': 'Duration of hospital stay'}], 'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Day 28', 'description': 'Survival at day 28'}], 'secondaryOutcomes': [{'measure': 'Duration of ventilation', 'timeFrame': 'Day 28', 'description': 'Duration of non-invasive ventilation and/or mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Exacerbation of COPD', 'Acute Exacerbation of Bronchiectasis', 'Acute Exacerbation of Asthma', 'Interstitial Lung Disease', 'Neuromuscular Diseases', 'Obesity Hypoventilation Syndrome', 'Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.', 'detailedDescription': "Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure.\n\nInclusion Criteria:\n\n* Chronic respiratory disease (COPD, ILD, OHS...)\n* Admission in ICU for acute respiratory failure\n* Patient's non-opposition\n\nExclusion Criteria:\n\n* Patients \\< 18 year-old\n* Protected patients\n* Pregnant women The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic respiratory disease (COPD, ILD, OHS...)\n* Admission in ICU for acute respiratory failure\n* Patient's non-opposition\n\nExclusion Criteria:\n\n* Patients \\< 18 year-old\n* Protected patients\n* Pregnant women"}, 'identificationModule': {'nctId': 'NCT04098094', 'acronym': 'DVD', 'briefTitle': 'Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases', 'organization': {'class': 'OTHER', 'fullName': "Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil"}, 'officialTitle': 'Prevalence of Right Ventricular Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases and Its Impact on Outcomes', 'orgStudyIdInfo': {'id': '2018-A03192-53'}}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre Demoule, MD, PhD', 'role': 'CONTACT', 'email': 'alexandre.demoule@aphp.fr', 'phone': '+33142167761'}, {'name': 'Athénaïs Boucly, MD', 'role': 'CONTACT', 'email': 'athenais.boucly@gmail.com', 'phone': '+33669286528'}], 'facility': 'Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Athénaïs Boucly, MD', 'role': 'CONTACT', 'email': 'athenais.boucly@gmail.com', 'phone': '+33669286528'}, {'name': 'Athénaïs Boucly, MD', 'role': 'CONTACT', 'email': 'athenais.boucly@gmail.com'}], 'overallOfficials': [{'name': 'Alexandre Demoule, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}