Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-04 @ 8:09 PM
Study NCT ID:
NCT05954351
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2023-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2465}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acute kidney injury', 'timeFrame': '90 days from inclusion'}, {'measure': 'duration of ventilation in survivors', 'timeFrame': '90 days from inclusion'}, {'measure': 'use of muscle paralysis', 'timeFrame': '90 days from inclusion'}, {'measure': 'vasopressor or inotrope administration', 'timeFrame': '90 days from inclusion'}, {'measure': 'occurrence of tracheostomy', 'timeFrame': '90 days from inclusion'}, {'measure': 'pneumothorax and thromboembolic complications', 'timeFrame': '90 days from inclusion'}, {'measure': 'use of immunomodulating drugs', 'timeFrame': '90 days from inclusion'}], 'primaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': '90 days from inclusion'}], 'secondaryOutcomes': [{'measure': 'Duration of ventilation', 'timeFrame': '90 days from inclusion'}, {'measure': '28-day ventilator free days', 'timeFrame': '90 days from inclusion'}, {'measure': '28-day, 90-day mortality', 'timeFrame': '90 days from inclusion'}, {'measure': 'ICU and hospital length of stay', 'timeFrame': '90 days from inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients. An observational study of ventilation practice and adjunctive therapies in critically ill, invasively ventilated COVID-19 patients during the first and second surge of COVID-19 in the Netherlands.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "invasively ventilation COVID-19 patients, admitted between March 1 to June 1, 2020, and October 1 to December 31, 2020, to one of the 22 participating ICU's in the Netherlands.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* receiving invasive ventilation or high-flow nasal oxygen for COVID-19 for SARS-CoV-2\n* admitted to one of the ICUs of the participating hospitals\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05954351', 'acronym': 'PRoVAcT-COVID', 'briefTitle': 'PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'PRactice of Ventilation and Adjunctive Therapies in COVID-19 Patients; What is the Optimal Ventilation Strategy in Critically Ill COVID-19 Patients, in Particular PEEP and the Moment of Switch to Pressure Support?', 'orgStudyIdInfo': {'id': 'PRoVAcT-COVID'}}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. Marcus J. Schultz', 'investigatorFullName': 'Prof. Dr. Marcus J. Schultz', 'investigatorAffiliation': 'Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)'}}}}