Impact of Serum Phosphorus Level Optimization on Weaning From Mechanical Ventilation in Adult ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The duration of mechanical ventilation.
研究概览
简要总结
The goal of this clinical trial is to test the impact of serum phosphorus level optimization on weaning from mechanical ventilation in adult ICU patients in Alexandria University Hospitals.
The main questions it aims to answer are:
- Does serum phosphorus level optimization affect the duration of mechanical ventilation?
- Is serum phosphorus level optimization associated with successful weaning from mechanical ventilation?
In critically ill patients, phosphorus supplementation is done using Sodium glycerophosphate pentahydrate solution.
详细描述
Investigators will document patients' data in terms of independent variables and will randomly allocate the participants into one of the two study groups mentioned below.
- Control group, defined by maintaining serum phosphorus level at ≥ 2.5 and < 3.5 mg/dL.
- Intervention group, defined by optimization of serum phosphorus P to ≥ 3.5 and ≤ 4.5 mg/dL (Average 4mg/dL).
Regression and comparative statistics will be used to determine whether the optimum serum phosphorus level offers a benefit in terms of the duration of mechanical ventilation and the success of weaning from mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult mechanically ventilated ICU patients.
- •Age ≥ 18 years.
排除标准
- •Age <18 years
- •Hypernatremia
- •Permanent or prolonged mechanical ventilation
- •Hyperphosphatemia which might occur in the following conditions:
- •Chronic kidney disease and end stage renal disease
- •Parathyroid disorders
- •Cancer patients at risk of tumor lysis syndrome
- •Immobility
- •Body weight < 50 Kg
研究组 & 干预措施
Intervention group
Optimization of serum phosphorus to ≥ 3.5 and ≤ 4.5 mg/dL (Average 4mg/dL) using Sodium glycerophosphate pentahydrate solution.
Sodium glycerophosphate pentahydrate 20ml solution (20 mmol glycerophosphate) dose will be given once daily till the target serum phosphorus level is achieved.
干预措施: Sodium glycerophosphate pentahydrate solution (Drug)
结局指标
主要结局
The duration of mechanical ventilation.
时间窗: 4 months
Comparison of mechanical ventilation days for patients in the two study groups.
Weaning from mechanical ventilation.
时间窗: 4 months
Association of serum phosphorus level optimization to ≥ 3.5 and ≤ 4.5 mg/dL with success of weaning from mechanical ventilation.
次要结局
- Length of ICU stay(4 months)
- ICU mortality(4 months)
- Cost effectiveness analysis(4 months)
研究者
Yasmin Mohamed Mahmoud Abdelghany
Master's student in Clinical Pharmacy and Pharmacy Practice, Alexandria University
Alexandria University