Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit. A Multicenter Prospective Observational Study Comparing Nicardipine and Urapidil
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Hypoxemia
研究概览
简要总结
In the context of postoperative hypertension in the intensive care units, or after resusitation of hypertensive patients, intravenous antihypertensive drugs are often used. Among those drugs, Nicardipine is an effective drug, but with side effects such as inhibition of pulmonary vasoconstriction. Only preclinical studies have investigated the pathophysiology of this mechanism, and no clinical study have proven its clinical relevance.
The aim of this study is to establish the incidence of Nicardipine induced hypoxemia and to compare it to another antihypertensive agent, Urapidil.
详细描述
Prospective observational study in 4 intensive care units in one general hospital and one university hospital.
Once Nicardipine or Urapidil infusion is started, data collection of respiratory related information such as type of ventilation, arterial partial pressure of oxygen, blood pressure, cardiac frequency.
Statistical analysis for two qualitative variables: Group (Nicardipine or Urapidil) and occurrence or worsening of hypoxemia. Secondary outcoumes analysed such as maximal drop of blood pressure, evolution of the PaO2/FiO2 ratio, length of hospital stay, duration of mechanical ventilation in the ventilated patients.
Analysis for different subgroups : Patients with known atelectasis, postoperative of cardiac surgery, neuro-intensive care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patient
- •With acute arterial systolic hypertension over 140mmHg
- •Requiring intravenous administration of one of the two following drugs : Urapidil or Nicardipine
排除标准
- •Patient ventilated Under Nitrogen Monoxyde
- •Contraindication to Nicardipine or Urapidil
- •Refusal of the patient or his relatives
- •Patient treated for pulmonary hypertension
研究组 & 干预措施
Nicardipine
Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Nicardipine.
干预措施: Antihypertensive Agents (Drug)
Urapidil
Major patients hospitalized in intensive care unit, with systolic hypertension, requiring administration of intravenous Urapidil.
干预措施: Antihypertensive Agents (Drug)
结局指标
主要结局
Hypoxemia
时间窗: During the twelve hours following start of drug infusion
Occurrence of worsening of hypoxemia
次要结局
- Efficacy of antihypertensive action(During the twelve hours following start of drug infusion)