Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT05556694
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2022-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cumulative Fluids Balance and Ventilator Associated Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-13', 'studyFirstSubmitDate': '2022-09-17', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilator-Associated Event', 'timeFrame': '7 days of mechanical ventilation', 'description': 'VAEs classified as ventilator-associated complication (VAC), infection-related ventilator-associated complication (IVAC), or the possible ventilator-associated pneumonia (PVAP).'}], 'secondaryOutcomes': [{'measure': 'Duration of MV', 'timeFrame': '7days', 'description': 'Duration of mechanical ventilation'}, {'measure': 'ICU length of stay', 'timeFrame': 'participants will be followed for the ICU length of stay, an expected average of 4 weeks', 'description': 'ICU length of stay'}, {'measure': 'ICU mortality', 'timeFrame': '28 day', 'description': 'ICU mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cumulative fluids balance', 'Ventilator Associated Event', 'Critically ill patients'], 'conditions': ['Ventilator Associated Event']}, 'referencesModule': {'references': [{'pmid': '35356099', 'type': 'BACKGROUND', 'citation': 'Unki P, Save S. Analysis of Fluid Balance as Predictor of Length of Assisted Mechanical Ventilation in Children Admitted to Pediatric Intensive Care Unit (PICU). Int J Pediatr. 2022 Mar 20;2022:2090323. doi: 10.1155/2022/2090323. eCollection 2022.'}, {'pmid': '34473657', 'type': 'BACKGROUND', 'citation': 'Wang W, Zhu S, He Q, Wang M, Kang Y, Zhang R, Ji P, Zou K, Klompas M, Zong Z, Sun X. Fluid Balance and Ventilator-Associated Events Among Patients Admitted to ICUs in China: A Nested Case-Control Study. Crit Care Med. 2022 Feb 1;50(2):307-316. doi: 10.1097/CCM.0000000000005227.'}, {'pmid': '30087192', 'type': 'BACKGROUND', 'citation': 'Chao WC, Chang WL, Wu CL, Chan MC. Using Objective Fluid Balance Data to Identify Pulmonary Edema in Subjects With Ventilator-Associated Events. Respir Care. 2018 Nov;63(11):1413-1420. doi: 10.4187/respcare.06221. Epub 2018 Aug 7.'}, {'pmid': '32728165', 'type': 'BACKGROUND', 'citation': 'Fang WF, Fang YT, Huang CH, Chen YM, Chang YC, Lin CY, Hung KY, Chang YT, Chen HC, Huang KT, Chang HC, Chen YC, Wang YH, Wang CC, Lin MC. Risk factors and associated outcomes of ventilator-associated events developed in 28 days among sepsis patients admitted to intensive care unit. Sci Rep. 2020 Jul 29;10(1):12702. doi: 10.1038/s41598-020-69731-3.'}, {'pmid': '35589091', 'type': 'BACKGROUND', 'citation': 'Klompas M, Branson R, Cawcutt K, Crist M, Eichenwald EC, Greene LR, Lee G, Maragakis LL, Powell K, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia, ventilator-associated events, and nonventilator hospital-acquired pneumonia in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2022 Jun;43(6):687-713. doi: 10.1017/ice.2022.88. Epub 2022 May 20.'}]}, 'descriptionModule': {'briefSummary': 'Fluid therapy is widely used to improve organ perfusion and survival in critically patients. Fluid therapy is an important component of intensive care management; however, optimal fluid management is unknown. Inadequate or excessive fluid resuscitation, on the other hand, is linked with a poor prognosis; the former can cause tissue hypo-perfusion and exacerbate organ dysfunction, while the latter can raise the risk of heart failure, pulmonary edema, and pleural effusions. Ventilator-associated lung injury (VALI) is a devastating complication of assisted mechanical ventilation (MV) and is one of the root causes of prolonged MV.', 'detailedDescription': 'This study is designed to test the association between cumulative fluids balance and ventilator associated events among critically ill patients.\n\nSetting: This research will be carried out in four General Intensive Care Units at two hospitals in El Beheira Governorate, Egypt.\n\n* For three months, from October 1, 2022 to January, 2023, all newly admitted mechanically ventilated patients who will fulfill the inclusion criteria and agree to participate will be screened on a daily basis.\n* The investigators will calculate cumulative fluid balance as daily fluid balance within four days of the event of interest. Cumulative fluid balance will be computed as the sum of daily fluid balances over the previous 24 hours, calculated by total fluid input minus total fluid output on a specific day of ICU admission over the first four calendar days of mechanical ventilation. Insensible fluid loss, such as perspiration or evaporative water loss related to respiration will not be routinely assessed and will not be included in the calculation of cumulative fluid balance. The cumulative fluid balance from day 0 to day 1 will be labelled as day 1, and the following days as day 2 and day 3. Cumulative fluid balance at day 3 refers to the cumulative fluid balance during the first four calendar days.\n* Variables associated with VAEs will be assessed for each patient including: age, gender, admission diagnosis, comorbidities; and ICU length of stay, APACH II score, Sofa score and duration of tracheal intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'critically ill patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥18 years,\n* mechanically ventilated for ≥48 h and remain in the intensive care ≥4 days.\n\nExclusion Criteria:\n\n* Patients with acute renal failure and needs dialysis,\n* increasing daily minimum positive end-expiratory pressure (PEEP) or Fio2 during MV treatment\n* hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT05556694', 'briefTitle': 'Cumulative Fluids Balance and Ventilator Associated Events', 'organization': {'class': 'OTHER', 'fullName': 'Damanhour University'}, 'officialTitle': 'Association Between Cumulative Fluids Balance and Ventilator Associated Events in Critically Ill Patients: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'ventilator associated events'}}, 'armsInterventionsModule': {'interventions': [{'name': 'calculation of cumulative fluid balance', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['VAEs assessment'], 'description': '\\- We will calculate cumulative fluid balance as daily fluid balance within four days of the event of interest. Cumulative fluid balance will be computed as the sum of daily fluid balances over the previous 24 hours, calculated by total fluid input minus total fluid output on a specific day of ICU admission over the first four calendar days of mechanical ventilation. Insensible fluid loss, such as perspiration or evaporative water loss related to respiration will not be routinely assessed and will not be included in the calculation of cumulative fluid balance. The cumulative fluid balance from day 0 to day 1 will be labelled as day 1, and the following days as day 2 and day 3. Cumulative fluid balance at day 3 refers to the cumulative fluid balance during the first four calendar days.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '045/3300376', 'city': 'Damanhūr', 'state': 'Behira', 'country': 'Egypt', 'facility': 'Faculty of nursing', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'overallOfficials': [{'name': 'Sahar Y Othman, Ass. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Nursing, Damanhour University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sahar Younes', 'investigatorAffiliation': 'Damanhour University'}}}}