Prospective Study Evaluating the Hemodynamic Impact of PAracetamol Administration in Patients Hospitalized in the REAnimation Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Measure frequency of low blood pressure following paracetamol administration
研究概览
简要总结
Paracetamol is commonly used in case of pain or fever. Few previously clinical studies has highlighted an arterial hypotension linked to intravenous administration of paracetamol. Currently, fewer data are available on the link of intravenous administration of paracetamol and effects on arterial tension. The aim of this study is to describe the frequency of occurrence of significative arterial hypotension within one hour following intravenous or per os administration of paracetamol . Other factors who can be associated to occurence of significative arterial hypotension will be also observe (for example age, weight, pain, vasopressor dosage or sedative...)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •18 years of age or older
- •Patient with arterial catheter
- •Indication of paracetamol's administration by the patient's attending practitioner.
- •No opposition to patient or support person participation in the study if the patient is unable to participate
- •ExclusionCriteria:
- •No Social Security Patient
- •Pregnant or nursing patient.
- •Patient with a legal protection measure
- •Hypersensitivity and/or allergy to paracetamol.
- •Contraindication to the use of paracetamol.
- •Patient opposition to health data collection.
排除标准
- 未提供
研究组 & 干预措施
Treatment with paracetamol
干预措施: paracetamol administration (Drug)
结局指标
主要结局
Measure frequency of low blood pressure following paracetamol administration
时间窗: One hour after administration of paracetamol
Proportion of patients with clinically significant low blood pressure occurring within one hour of administration of paracetamol IV or per os. Clinically significant low blood pressure is defined as an average blood pressure of less than 60 mmHg and/or a decrease in average blood pressure of more than 15%, and/or need for vascular filling and/or initiation or increase of the dose of noradrenaline
次要结局
- identify predictors linked to paracetamol administration route(One hour after administration of paracetamol)
- identify predictors linked to paracetamol dosage(One hour after administration of paracetamol)
- Measure of blood pressure following paracetamol administration according to IGS II score(One hour after administration of paracetamol)
- Measure of blood pressure following paracetamol administration according to SOFA score(One hour after administration of paracetamol)