Association Between Cumulative Fluids Balance and Ventilator Associated Events in Critically Ill Patients: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Ventilator-Associated Event
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥18 years,
- •mechanically ventilated for ≥48 h and remain in the intensive care ≥4 days.
排除标准
- •Patients with acute renal failure and needs dialysis,
- •increasing daily minimum positive end-expiratory pressure (PEEP) or Fio2 during MV treatment
- •hemodynamic instability
结局指标
主要结局
Ventilator-Associated Event
时间窗: 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).
次要结局
- Duration of MV(7days)
- ICU mortality(28 day)
- ICU length of stay(participants will be followed for the ICU length of stay, an expected average of 4 weeks)
研究者
Sahar Younes
Assistant professor
Damanhour University