Cumulative Fluids Balance and Ventilator Associated Events

Completed

• Conditions: Ventilator Associated Event

• Registration Number: NCT05556694
• Lead Sponsor: Damanhour University

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.

Study Timeline

• Study First Submitted: 2022-09-17
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Study Start: 2022-10-18
• Primary Completion: 2023-04-18
• Study Completion: 2023-05-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-13
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventilator-Associated Event	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).

Secondary Outcome Measures

Name	Time	Method
Duration of MV	7days	Duration of mechanical ventilation
ICU mortality	28 day	ICU mortality
ICU length of stay	participants will be followed for the ICU length of stay, an expected average of 4 weeks	ICU length of stay

Trial Locations

Locations (1)

Faculty of nursing; 🇪🇬 Damanhūr, Behira, Egypt