REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19. The Non-randomized, Non-controlled, Pilot, Open, Mono-centric REHSCU Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- composite endpoint including a combination of cardio-vascular and sedation events, from baseline (before infusion) to 8 hours, after the beginning of Remimazolam infusion
研究概览
简要总结
The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortage in masks, mechanical ventilation machines and common medications such as hypnotics. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. The Principal Investigator proposes to perform a pilot study assessing the benefit-risk ratio of Remimazolam (a novel benzodiazepine with a short half-life) in the critical care units of Nantes University Hospital during the COVID-19 pandemic.
详细描述
The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortage in masks, mechanical ventilation machines and common medications such as hypnotics. The reasons for such shortage are multiple: dramatic increase of the demand, production discontinuation because of shutdowns in multiple countries, and withholding of products by producing countries. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. Remimazolam is a novel benzodiazepine with a short half-life that has been administered in patients undergoing major surgery, as well as in the intensive care unit. The Principal Investigator proposes to perform a pilot study assessing the benefit-risk ratio of Remimazolam in the critical care units of Nantes University Hospital during the COVID-19 pandemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years old
- •Inclusion in the first 96 hours after ICU admission, after clinical stabilization according to the attending physician's discretion.
- •Expected duration of general anaesthesia ≥ 24 hours
排除标准
- •Patients more than 85 years-old
- •Refusal to participate
- •Severe patients with moribund state within the 24 hours after admission to the ICU
- •Withdrawal of Life Sustaining Therapies within the 24 hours after admission to the ICU
- •Any pregnant or breast-feeding patient,
- •Patients with known anaphylactic reactions to benzodiazepines, flumazenil, or a medical condition such that these agents are contraindicated (according to local label)
- •Patients with allergy/hypersensitivity to bovine lactose, dextran or any other excipient in the remimazolam product
- •Presence of acute alcoholic or illicit drug intoxication or benzodiazepine intoxication
- •Inclusion in another clinical (drug) trial
- •Patient under guardianship or trusteeship
- •Patient under judicial protection
- •Severe hepatic impairment defined as a Child-Pugh score > 10.
研究组 & 干预措施
Remimazolam
Patients will receive an infusion of Remimazolam for a maximum duration of 48 hours.
The dose of Remimazolam will be adapted according to our ICU protocol of analgesia-sedation management, based on validated scale (Richmond Assessment Sedation Scale)
干预措施: Remimazolam (Drug)
结局指标
主要结局
composite endpoint including a combination of cardio-vascular and sedation events, from baseline (before infusion) to 8 hours, after the beginning of Remimazolam infusion
时间窗: 8 hours after the beginning of infusion.
For Safety: Cardiovascular event: Hypotension will be defined as a Mean Arterial Pressure ≤65mmHg or an increase ≥50% of the dose of norepinephrine (if appropriate), sustained over one hour after the beginning of Remimazolam. For Efficacy: Sedation event: the investigator will check if Remimazolam provides an adequate level of sedation assessed with the Richmond Assessment Sedation Scale. The level of sedation will be set by the attending physician and is usually set at-1/0. The investigator will also monitor the need to use standard hypnotic drugs within this time frame as further medication (propofol, midazolam, dexmedetomidine) in case of Remimazolam inefficacy (Richmond Assessment Sedation Scale).
次要结局
- Heart rate(3 days)
- Adverse Events (all grades), related to Remimazolam.(5 days)
- Electrocardiogram (ECG)(3 days)
- Other sedatives.(3 days)
- Laboratory parameters: bilirubin(4 days)
- Extubation failure defined as the need to intubate a patient in the 96 hours following extubation.(28 days)
- Length of Mechanical ventilation.(28 days)
- Arterial pressure(3 days)
- Laboratory parameters: ionogram(4 days)
- Sedation.(3 days)
- Wake-up time.(3 days)
- Pharmacokinetics of Remimazolam and its metabolites (CNS 7054): Maximum Plasma Concentration.(3 days)
- Laboratory parameters : blood gas(4 days)
- Laboratory parameters: creatinine(4 days)
- Death.(28 days)
- Dose of norepinephrine(3 days)
- Laboratory parameters: albumin(4 days)
- Laboratory parameters: liver enzymes(4 days)
- Laboratory parameters: phosphorus(4 days)
- Laboratory parameters: magnesium(4 days)
- Pharmacodynamics Remimazolam and its metabolites (CNS 7054): steady state plasma levels and elimination.(3 days)
- Laboratory parameters: haemoglobin(4 days)
- Laboratory parameters: platelet count(4 days)
- Laboratory parameters: white blood cell count(4 days)