NCT05556694

Cumulative Fluids Balance and Ventilator Associated Events

Association Between Cumulative Fluids Balance and Ventilator Associated Events in Critically Ill Patients: a Prospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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.

Conditions

• Ventilator Associated Event

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	calculation of cumulative fluid balance	\- 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.

Timeline

• Start date: 2022-10-18
• Primary completion: 2023-04-18
• Completion: 2023-05-18
• First posted: 2022-09-27
• Last updated: 2023-08-15

Locations

1 site across 1 country: Egypt