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:
Damanhour University
Organization:
Study Overview
Official Title:
Association Between Cumulative Fluids Balance and Ventilator Associated Events in Critically Ill Patients: a Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: