Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-27 @ 5:13 AM
Study NCT ID:
NCT05968066
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2023-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-21', 'size': 234976, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-23T09:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2508}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pre-defined subgroup analysis in patients admitted with burns', 'timeFrame': '90 days', 'description': 'All aforementioned outcomes in patients with burns'}, {'measure': 'Pre-defined subgroup analysis in patients admitted with acute respiratory distress syndrome', 'timeFrame': '90 days', 'description': 'All aforementioned outcomes in patients with acute respiratory distress syndrome'}, {'measure': 'Pre-defined subgroup analysis in patients admitted with sepsis', 'timeFrame': '90 days', 'description': 'All aforementioned outcomes in patients with sepsis'}], 'primaryOutcomes': [{'measure': 'Composite of various aspects of fluid therapy', 'timeFrame': 'seven days', 'description': 'Including total volumes of types of fluids administered in the first three days after ICU admission and total volume of fluids infused in the first seven days of ICU admission'}], 'secondaryOutcomes': [{'measure': 'Timing of start of continuous administration of vasopressors.', 'timeFrame': 'seven days', 'description': 'Timing of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral)'}, {'measure': 'Duration of vasopressor therapy', 'timeFrame': 'seven days', 'description': 'In days'}, {'measure': 'Types of vasopressors', 'timeFrame': 'seven days', 'description': 'The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed'}, {'measure': 'Concentration of types of vasopressors', 'timeFrame': 'seven days', 'description': 'The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route'}, {'measure': 'Timing of start of administered diuretics.', 'timeFrame': 'seven days', 'description': 'Time between start of invasive ventilation and administration of diuretics in days'}, {'measure': 'Duration of diuretic therapy', 'timeFrame': 'seven days', 'description': 'In days'}, {'measure': 'Types of diuretics', 'timeFrame': 'seven days', 'description': 'The type of diuretics that are prescribed'}, {'measure': 'Bolus or continous infusion of diuretics', 'timeFrame': 'seven days'}, {'measure': 'Cumulative fluid balances', 'timeFrame': 'seven days'}, {'measure': 'Daily urine output', 'timeFrame': 'seven days'}, {'measure': 'Incidence of atrial arrythmias', 'timeFrame': '7 days'}, {'measure': 'Incidence of acute respiratory distress syndrome', 'timeFrame': '7 days'}, {'measure': 'Incidence of renal replacement therapy', 'timeFrame': '7 days'}, {'measure': 'Incidence of need for renal replacement therapy at ICU discharge.', 'timeFrame': '90 days'}, {'measure': 'Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluid Therapy', 'Vasopressor', 'Resuscitation', 'Deresuscitation', 'Fluids'], 'conditions': ['Fluid Therapy', 'Vasopressor Therapy', 'Critical Illness', 'Invasive Ventilation']}, 'referencesModule': {'references': [{'pmid': '39507456', 'type': 'DERIVED', 'citation': 'PRoFLUID-Investigators. Practice of Fluid and Vasopressor Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)-study protocol for an international multicenter observational cohort study. Ann Transl Med. 2024 Oct 20;12(5):92. doi: 10.21037/atm-23-1957. Epub 2024 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this woldwide observational study is to investigate various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients. The main questions it aims to answer are:\n\n* What is the global current practice of fluid and vasopressor therapy?\n* What are associations between this practice and clinical outcomes?\n\nParticipating intensive care units will gather detailed information about fluid and vasopressor therapy prescribed to participants. Participating intensive care units will also gather information about participant outcomes such as duration of invasive ventilation, length of stay and mortality', 'detailedDescription': 'Rationale:\n\nThe worldwide practice of fluid and vasopressor therapy in critically ill invasively ventilated patients is uncertain. Indeed, it is unclear whether there is a difference in fluid and vasopressor therapy in these patients between Low- and Middle-income Countries (LMICs) and High-income Countries (HICs).\n\nObjective:\n\nTo determine various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients in LMICs and HICs.\n\nHypothesis:\n\nThere is substantial worldwide variation in practice of fluid and vasopressor therapy in critically ill invasively ventilated patients.\n\nStudy design:\n\nInternational, multicenter, observational study in critically ill invasively ventilated patients; data are captured during a predefined period per geographic region or country.\n\nStudy population:\n\nCritically ill invasively ventilated patients.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nBecause of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts or electronic medical records systems is of no risk to the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill invasively ventilated patients that receive ventilation for at least 24 hours.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to a participating intensive care unit;\n* Receiving invasive ventilation; and\n* Duration of ventilation \\> 24 hours.\n\nExclusion Criteria:\n\n* Age \\< 16 years;\n* Patients transferred under invasive ventilation from another intensive care unit.'}, 'identificationModule': {'nctId': 'NCT05968066', 'acronym': 'PRoFLUID', 'briefTitle': 'Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study', 'orgStudyIdInfo': {'id': 'PRoFLUID'}}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Pieter R. Tuinman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}, {'name': 'Frederique Paulus, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location AMC'}, {'name': 'Marcus J. Schultz, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol Oxford Tropical Medicine Research Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mahidol Oxford Tropical Medicine Research Unit', 'class': 'OTHER'}, {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Prof. Dr. Marcus J. Schultz', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}