Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT07051967
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impairment in at least one PICS domain (mobility, cognition, and/or mental health)', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Impairment in at least one PICS domain (mobility, cognition, and/or mental health) after discharge from the ICU, assessed at the time of presentation to the PICS outpatient clinic. The planned PICS outpatient presentation takes place 3 and 6 months (ranging from 1 month to 3 years) after the initial ICU stay.'}], 'secondaryOutcomes': [{'measure': 'Catecholamine therapy', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Catecholamine therapy during intensive care unit (ICU) treatment is measured in doses and duration.'}, {'measure': 'Extracorporeal Membrane Oxygenation treatment', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Extracorporeal Membrane Oxygenation treatment in the ICU Yes or No'}, {'measure': 'Need for ventilation during ICU treatment', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Need for ventilation during ICU treatment and, if so, ventilation route (non-invasive and invasive, endotracheal tube and tracheostomy tube) and duration of ventilation'}, {'measure': 'Duration of ventilation during ICU treatment', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Duration of ventilation during ICU treatment is measured in hours'}, {'measure': 'Oxygenation index', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Oxygenation index/Horowitz index is defined as the ratio of the arterial partial pressure of oxygen (PaO₂, in mmHg) to the fraction of inspired oxygen (FiO₂, expressed as a decimal).'}, {'measure': 'Severity of illness', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Severity of illness during ICU treatment is assessed with validated intensive care unit scores.'}, {'measure': 'Incidence of delirium', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Incidence of delirium in the ICU is measured with validated delirium scores.'}, {'measure': 'Duration of delirium', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Duration of delirium in the ICU is measured in days'}, {'measure': 'Sedation Medications', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Kind of medications required for sedation.'}, {'measure': 'Sedation dosage', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'The amount of drug required for sedation.'}, {'measure': 'Duration of sedation', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Duration of sedation is measured in days.'}, {'measure': 'Depth of sedation', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Depth of sedation during ICU treatment'}, {'measure': 'Continuous muscle relaxation', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Continuous muscle relaxation during ICU treatment'}, {'measure': 'Vaccination status', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Vaccination status at the start of ICU treatment'}, {'measure': 'COVID-19-specific immunotherapy', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'COVID-19-specific immunotherapy (e.g., tocilizumab, dexamethasone, baricitinib) during ICU treatment'}, {'measure': 'Type of Anti-infective therapy', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Type of anti-infective therapy during ICU treatment'}, {'measure': 'Duration of Anti-infective therapy', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Duration of anti-infective therapy during ICU treatment is measured in days.'}, {'measure': 'Week of pregnancy', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Week of pregnancy during ICU treatment in the pregnant women group'}, {'measure': 'Need for a cesarean section', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Need for a cesarean section in the pregnant women group, yes or no.'}, {'measure': 'Organ complications', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Organ complications, including bleeding and pregnancy complications during hospital treatment. Data from patient records.'}, {'measure': 'Nutrition', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Nutrition (enteral vs. parenteral) during ICU treatment'}, {'measure': 'Dialysis 1', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Dialysis during ICU treatment (binary)'}, {'measure': 'Dialysis 2', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Dialysis during ICU treatment (duration)'}, {'measure': 'Intensive care unit mortality', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Data from patient records'}, {'measure': 'Hospital mortality', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Data from patient records'}, {'measure': '90-day mortality', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Data from patient records'}, {'measure': '180-day mortality', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Data from patient records'}, {'measure': 'Intensive care unit length of stay', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Participants are followed up for the duration of intensive care unit stay, an expected average of 2 days'}, {'measure': 'Duration of Hospital stay', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Participants are followed up for the duration of hospital stay, an expected average of 7 days'}, {'measure': 'Grip strength Test', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Grip strength at the time of presentation to the PICS outpatient clinic is measured with a dynamometer.'}, {'measure': 'Mobility', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Mobility at the time of presentation to the PICS outpatient clinic is measured with the Timed Up-and-Go (TUG).'}, {'measure': 'Cognition 1', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Cognition 1 at the time of presentation to the PICS outpatient clinic is measured with the MiniCog. The MiniCog consists of two items, the word recall test and the clock-drawing test. Performance in these test is rated on a scale ranging from 0 - 5, with \\<3 points indicating a suspicion of dementia.'}, {'measure': 'Cognition 2', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Cognition 2 at the time of presentation to the PICS outpatient clinic is measured with the Animal Naming Test'}, {'measure': 'Mental health', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Mental health at the time of presentation to the PICS outpatient clinic is measured with Patient Health Questionnaire-4 (It comprises the first two questions of the depression module of the PHQ-D \\[PHQ-2\\] and the first two questions of the module for assessing generalized anxiety \\[GAD-2\\]) and patient questionnaire with subjective patient assessment.'}, {'measure': 'PBQ Parent-Child Relationship Questionnaire', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'PBQ at the time of presentation to the PICS outpatient clinic. This questionnaire is a 25-question self-completion questionnaire, which was developed in order to recognize disorders in the mother-child relationship at an early stage.\n\nThe questionnaire is made up of 4 scales. Scale 1 Delayed attachment cut-off 12, Scale 2 Rejection and anger cut-off 17, Scale 3 Anxiety cut-off 10 and Scale 4 Risk of child abuse cut-off 3.'}, {'measure': 'Edinburgh Postpartum Depression Questionnaire (EPDS)', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'The Edinburgh Postnatal Depression Scale (EDPS) was developed to identify women who may have postpartum depression. Each answer is given a score of 0 to 3 .The maximum score is 30. A score of more than 10 suggests minor or major depression may be present.'}, {'measure': 'Health-related quality of life', 'timeFrame': '27.03.2020-06.05.2024', 'description': 'Health-related quality of life at the time of presentation to the PICS outpatient clinic is measured with EQ-5D-5L questionnaire. Higher Score indicate better Healt-related quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Acute Respiratory Distress Syndrome Due to COVID-19', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to characterize patients in the Post-Intensive-Care-Syndrome (PICS) outpatient clinic based on routine data and to evaluate their treatment outcome over the course of their treatment. For this purpose, data sets from approx. 40 patients who were treated in the intensive care unit subsequently evaluated in the PICS outpatient clinic between March 27, 2020, and May 6, 2024, will be analyzed.', 'detailedDescription': 'This is a retrospective comparison of approximately 13 pregnant patients and approximately 27 non-pregnant patients who developed respiratory failure (also known as acute respiratory distress syndrome, or ARDS) due to COVID-19 infection. The analysis is based on routine treatment data from the Post-Intensive Care Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), as well as intensive care treatment data, primarily from the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK). In some cases, additional data were obtained from the Medical Clinic for Nephrology and Internal Intensive Care Medicine (CCM/CVK/CBF), the Medical Clinic specializing in Hepatology and Gastroenterology (CCM/CVK), and the Department of Infectiology, Pulmonology, and Intensive Care Medicine (CCM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult female pregnant and non-pregnant patients who were admitted to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine, Charité - Universitaetsmedizin Berlin between March 27, 2020 and May 6, 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 years and older\n* Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024.\n* COVID-19 infection in temporal assocoation with the intensive care unit admission.\n* Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment.\n* Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay.\n\nExclusion Criteria:\n\n* Gender: Male\n* Diagnosis: Non-COVID or no respiratory failure'}, 'identificationModule': {'nctId': 'NCT07051967', 'briefTitle': 'Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19', 'orgStudyIdInfo': {'id': 'CovPreg'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female pregnant patients with COVID-19 related Acute respiratory distress syndrome', 'description': '* Pregnancy at the time of initial hospital admission (not necessarily at the time of transfer to Charité - Universitätsmedizin Berlin).\n* Age: 18 years and older\n* Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024.\n* COVID-19 infection in temporal association with the intensive care unit admission.\n* Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment.\n* Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay'}, {'label': 'Female non-pregnant patients with COVID-19 related Acute respiratory distress syndrome', 'description': '* No pregnancy at the time of admission.\n* Age: 18 years and older\n* Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024.\n* COVID-19 infection in temporal association with the intensive care unit admission.\n* Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment.\n* Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Claudia Spies, MD. Prof.', 'role': 'CONTACT', 'email': 'claudia.spies@charite.de', 'phone': '+49 30 450 55 11 02'}, {'name': 'Claudia Spies, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karin Steinecke, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicolas Paul, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sonya Arustamyan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Claudia Spies, MD Prof.', 'role': 'CONTACT', 'email': 'claudia.spies@charite.de', 'phone': '+49 30 450 551102'}], 'overallOfficials': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitaetsmedizin Berlin', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}