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OpenTrials
Completed

NCT Number: NCT05556694

Cumulative Fluids Balance and Ventilator Associated Events

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of nursing

Damanhur, Beheira, 045/3300376, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

calculation of cumulative fluid balance

Diagnostic Test
  • 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.

Other names: VAEs assessment

Primary outcomes

  1. 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).

Secondary outcomes

  1. Duration of MV

    Time frame: 7days

    Duration of mechanical ventilation

  2. 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

  3. ICU mortality

    Time frame: 28 day

    ICU mortality

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2022
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.