Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-28 @ 5:21 PM
Study NCT ID:
NCT04619368
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2020-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome Caused by COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'C000657744', 'term': 'postintensive care syndrome'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-05', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care', 'timeFrame': 'month 12', 'description': 'Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care'}], 'secondaryOutcomes': [{'measure': 'psychological disorders measured by QIDS', 'timeFrame': 'Month 3', 'description': 'psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms'}, {'measure': 'psychological disorders measured by STAI-YA', 'timeFrame': 'Month 3', 'description': 'psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety'}, {'measure': 'psychological disorders measured by QIDS', 'timeFrame': 'Month 6', 'description': 'psychological disorders measured by QIDS : Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms'}, {'measure': 'psychological disorders measured by STAI-YA', 'timeFrame': 'Month 6', 'description': 'psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety'}, {'measure': 'psychological disorders measured by QIDS', 'timeFrame': 'Month 12', 'description': 'psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms'}, {'measure': 'psychological disorders measured by STAI-YA', 'timeFrame': 'Month 12', 'description': 'psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety'}, {'measure': 'quality of life by EQL-5', 'timeFrame': 'Month 3', 'description': 'Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life) higher score is higher quality of life'}, {'measure': 'quality of life by EQL-5', 'timeFrame': 'Month 6', 'description': 'Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life'}, {'measure': 'quality of life by EQL-5', 'timeFrame': 'Month 12', 'description': 'Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life'}, {'measure': 'nutritional status', 'timeFrame': 'Month 3', 'description': 'nutritional status measured by Nutritional Risk Screening 2002'}, {'measure': 'nutritional status', 'timeFrame': 'Month 6', 'description': 'nutritional status measured by Nutritional Risk Screening 2002'}, {'measure': 'nutritional status', 'timeFrame': 'Month 12', 'description': 'nutritional status measured by Nutritional Risk Screening 2002'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-intensive care Syndrome', 'Acute Respiratory Distress Syndrome', 'quality of life', 'intensive care unit', 'PTSD', 'follow-up after ICU', 'COVID-19'], 'conditions': ['Human ARDS', 'Coronavirus Infection']}, 'descriptionModule': {'briefSummary': 'For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS.\n\nThe primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).', 'detailedDescription': "Many studies have showed that ARDS survivors keep, even a long time after hospitalization, a functional respiratory disability, resulting on one hand from impaired diffusion of carbon monoxide, and on the other hand from a muscular weakness. Indeed, 67% of patients ventilated more than 10 days have a neuromyopathy whose recovery is uncertain.\n\nBeside this, Long-term quality of life is worse than in general population, due in particular to depressive and anxiety disorders such as post-traumatic syndrome disorder with a prevalence around 22% after one year.\n\nThe follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'cohort of all COVID patients who went out alive from intensive care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patient\n* hospitalized in intensive care of the CHU anesthesia-intensive care unit (Rangueil, URM, Neurosurgery)\n* intubated and ventilated\n* supported for an ARDS according to the Berlin criteria (PaO2 / FiO2 ratio \\<300 mmHg)\n* with an rt-PCR positive to SARS-CoV-2\n* affiliated to the french social security\n\nExclusion Criteria:\n\n* minor patient\n* patient under protective measure\n* ARDS in the pandemic context but rt-PCR negative to SARS-CoV-2'}, 'identificationModule': {'nctId': 'NCT04619368', 'acronym': 'RE-CoV-ERY', 'briefTitle': 'Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome Caused by COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-CoV-2 (COVID-19)', 'orgStudyIdInfo': {'id': 'RC31/20/0219'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Follow up calls', 'type': 'OTHER', 'description': "The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit."}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Fanny BOUNES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}