- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05556694
Cumulative Fluids Balance and Ventilator Associated Events
August 13, 2023 updated by: Sahar Younes, Damanhour University
Association Between Cumulative Fluids Balance and Ventilator Associated Events in Critically Ill Patients: a Prospective Cohort Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is designed to test the association between cumulative fluids balance and ventilator associated events among critically ill patients.
Setting: This research will be carried out in four General Intensive Care Units at two hospitals in El Beheira Governorate, Egypt.
- 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.
- 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.
- 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.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Behira
-
Damanhūr, Behira, Egypt, 045/3300376
- Faculty of Nursing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
critically ill patients
Description
Inclusion Criteria:
- aged ≥18 years,
- mechanically ventilated for ≥48 h and remain in the intensive care ≥4 days.
Exclusion Criteria:
- Patients with acute renal failure and needs dialysis,
- increasing daily minimum positive end-expiratory pressure (PEEP) or Fio2 during MV treatment
- hemodynamic instability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilator-Associated Event
Time Frame: 7 days of mechanical ventilation
|
VAEs classified as ventilator-associated complication (VAC), infection-related ventilator-associated complication (IVAC), or the possible ventilator-associated pneumonia (PVAP).
|
7 days of mechanical ventilation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of MV
Time Frame: 7days
|
Duration of mechanical ventilation
|
7days
|
ICU length of stay
Time Frame: participants will be followed for the ICU length of stay, an expected average of 4 weeks
|
ICU length of stay
|
participants will be followed for the ICU length of stay, an expected average of 4 weeks
|
ICU mortality
Time Frame: 28 day
|
ICU mortality
|
28 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sahar Y Othman, Ass. Prof., Faculty of Nursing, Damanhour University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 18, 2022
Primary Completion (Actual)
April 18, 2023
Study Completion (Actual)
May 18, 2023
Study Registration Dates
First Submitted
September 17, 2022
First Submitted That Met QC Criteria
September 22, 2022
First Posted (Actual)
September 27, 2022
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 13, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- ventilator associated events
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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