Effect of Targeting Upper Normal Serum Magnesium Levels on Norepinephrine Requirements in Septic Shock Patients: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total cumulative dose of norepinephrine
研究概览
简要总结
The goal of this clinical trial is to assess the effect of targeting upper normal serum magnesium levels on norepinephrine requirements in adult patients with septic shock.
The main questions it aims to answer are:
- Does maintaining upper normal serum magnesium levels lower the total cumulative dose and duration of norepinephrine therapy?
- Does this approach reduce the intensive care unit (ICU) length of stay, duration of mechanical ventilation and mortality?
This study will compare an intervention group to a control group to see the effect of targeting upper normal serum magnesium levels.
Participants will:
- Have their serum magnesium levels assessed at baseline (Day 0), at three-day intervals (Days 3, 6, 9) thereafter and on the day of norepinephrine discontinuation.
- Receive individualized intravenous magnesium sulfate infusions to achieve and maintain the target serum magnesium levels.
- Have their demographic data collected and be monitored closely for clinical data, vital signs, Mean Arterial Pressure (MAP), urine output and laboratory parameters.
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
- •Male and female adult patients (aged ≥18 years) diagnosed with septic shock.
- •Resistant septic shock that requires corticosteroids.
排除标准
- •Pregnancy.
- •Baseline hypermagnesemia (serum magnesium level > 2.3 mg/dL).
- •Renal impairment with creatinine clearance (CrCl) < 10 ml/min.
- •Mixed shock.
研究组 & 干预措施
Control group
Patients will receive standard care to maintain serum magnesium levels (1.7 - 1.9 mg/dL).
干预措施: standard care treatment (Other)
Intervention group
Patients will receive intravenous magnesium sulfate infusion to achieve and maintain upper normal serum magnesium levels (2.0 - 2.3 mg/dL).
干预措施: magnesium sulfate (Drug)
结局指标
主要结局
Total cumulative dose of norepinephrine
时间窗: Up to 60 days.
Total cumulative dose of norepinephrine administered to the patient, measured in µg/kg.
Duration of norepinephrine therapy
时间窗: Up to 60 days.
The time from the initiation of norepinephrine until discontinuation, measured in hours.
次要结局
- ICU length of stay(Up to 60 days.)
- Duration of mechanical ventilation(Up to 60 days.)
- Mortality(Up to 60 days.)