Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
Study NCT ID:
NCT06729268
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2024-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-28', 'studyFirstSubmitDate': '2024-12-07', 'studyFirstSubmitQcDate': '2024-12-07', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the prevalence of conditions allowing the performance fluid responsiveness tests during admission to the intensive care unit.', 'timeFrame': 'Six hours after admission to the intensive care unit', 'description': 'The primary aim of the study is to assess the prevalence of conditions allowing the performance fluid responsiveness tests during admission to the intensive care unit.'}], 'secondaryOutcomes': [{'measure': 'To assess which fluid responsiveness test based on heart-lung interactions can be applied most often during admission to the intensive care unit', 'timeFrame': 'Six hours after admission to the intensive care unit', 'description': 'The secondary aim of the study is to assess which fluid responsiveness test based on heart-lung interaction can be applied most often during admission to the intensive care unit'}, {'measure': 'To assess the percentage of patients in shock whom fluid responsiveness tests can be performed during admission to the intensive care unit', 'timeFrame': 'Six hours from the admission to the intensive care unit.', 'description': 'Secondary aim include an assessment the percentage of patients in shock whom fluid responsiveness tests can be performed during admission to the intensive care unit.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shock Circulatory', 'Heart Failure', 'Hypovolemia']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the prevalence of conditions allowing the performance fluid responsiveness tests in critically ill patients during admission to the intensive care unit.', 'detailedDescription': 'Patients admitted to the intensive care unit are very often hemodynamically unstable. In these cases fluid responsiveness tests should be performed to assess whether the patient would benefit from the fluid administration.\n\nHowever, fluid responsiveness tests have many limitations including lack of spontaneous breathing, necessity of invasive mechanical ventilation with tidal volume of \\> 8 mL/kg ideal body weight, regular hearth rhythm, and lack of abdominal hypertension.\n\nIn the study, the investigators evaluated the prevalence of conditions enabling the performance fluid responsiveness tests in patients admitted to the intensive care unit. An assessment was performed within the six hours after admission to the intensive care unit. Evaluation was based on transthoracic echocardiography, clinical examination of the patients, and data derived from anamnesis.\n\nThe following fluid responsiveness tests were included into assessment: passive leg raising test, end-expiratory occlusion test, pulse pressure variation, stroke volume variation, velocity time integral variation in left ventricle output track, tidal volume challenge, inferior vena cava diameter variation, and superior vena cava diameter variation.\n\nThe aim of the study was to assess how many patients have the conditions allowing performance fluid responsiveness tests during admission to the intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to the intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Adult patients admitted to the intensive care unit\n\nExclusion Criteria:\n\n1. Age under 18\n2. The researcher unavailable in the intensive care unit\n3. Patient assessment cannot be completed within the first six hours after admission to the ICU'}, 'identificationModule': {'nctId': 'NCT06729268', 'briefTitle': 'Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Uniwersytecki Szpital Kliniczny w Opolu'}, 'officialTitle': 'Possibility of Applying Fluid Responsiveness Tests in Critically Ill Patients During Admission to the Intensive Care Unit - a Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'PossFluRespTests'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated in the intensive care unit', 'description': 'Patients treated in the intensive care unit during the first six hours after admission.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45-401', 'city': 'Opole', 'state': 'Opole Voivodeship', 'country': 'Poland', 'facility': 'Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uniwersytecki Szpital Kliniczny w Opolu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ryszard Gawda', 'investigatorAffiliation': 'Uniwersytecki Szpital Kliniczny w Opolu'}}}}