Extracorporeal Membrane Oxygenation Support for Middle East Respiratory Syndrome Induced Respiratory Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Mortality rate
研究概览
简要总结
A highly pathogenic human coronavirus causing respiratory disease emerged in Saudi Arabia in 2012. This viral infection termed Middle East respiratory syndrome coronavirus (MERS-CoV) is associated with high mortality rate in approximately 36% of reported patients.
The World Health Organization (WHO) reported 1,374 laboratory-confirmed worldwide infections, including at least 490 related deaths, from September, 2012, to July 24, 2015.2 The higher incidence of MERS-CoV infections in Saudi Arabia may be related to multiple factors, including seasonality, increased proactive screening, poor infection control measures, low relative humidity, and high temperature.
Infected patients with MERS-CoV usually have abnormal findings on chest radiography, ranging from subtle to extensive unilateral and bilateral abnormalities. MERS progresses rapidly to respiratory failure, in approximately 2/3 of infected patients, which has a high mortality rate, particularly in immunocompromised patients.
Extracorporeal membrane oxygenation (ECMO) has emerged as a rescue therapy in patients with refractory hypoxemia during the H1N1 epidemic.The use of veno-venous (VV)-ECMO provides respiratory support for patients with respiratory failure, whereas the use of veno-arterial (VA)-ECMO could be helpful in those with cardiorespiratory failure.10 However, the survival rate of the infected patients with H1N1 who required the use of ECMO varies considerably among the Caucasian and Asian countries (90% survival in Sweden and 83% in the UK13 vs. 35% in Japan). This large discrepancy could be explained with lack of satisfactory equipment, therapeutic guidelines, training of staff, and effective systems allowing patient transfer to the dedicated ECMO centres.
Guery and co-investigators described the use of ECMO in two French patients with cardiorespiratory failure secondary to MERS-CoV infection.This has been extended for treatment of refractory hypoxemic respiratory failure during the Saudi MERS-CoV outbreak.
详细描述
The Saudi Ministry of Health has implemented a national ECMO program since 2014 in three major cities including Jeddah, Al Madinah and Riyadh which have most of the reported infected cases with MERS-CoV. The Saudi ECMO program provides a rapid transportation chain system (Medevac system), adequate number of intensive care beds and ECMO machines, and highly trained perfusionists and staff.
The investigators hypothesized that the early use of ECMO for treatment of severe acute hypoxemic respiratory failure, defined as a ratio of the PaO2 to the fraction of inspired oxygen (PaO2/FiO2 ratio) less than 80 despite optimized ventilator management, in infected patients with MERS-CoV, would be associated with reduced in-hospital mortality rate.
Patient Selection:
The investigators obtained a centralized ethics approval from the Ministry of Health to avoid delays and to facilitate the conduct of this timely important study. Eligible patients or their legal guardians were contacted to request their participation and obtaining of their written consent.
Patients who are 18 years or older who received ECMO support for MERS-CoV associated hypoxemic respiratory failure were included. MERS-CoV infection is defined using the WHO case definition. A positive polymerase chain reaction (PCR) on nasopharyngeal or oropharyngeal swabs, sputum, tracheal aspirate, or bronchial alveolar lavage is sufficient to establish the diagnosis of infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Positive infection with Middle East Respiratory Syndrome virus
- •Refractory hypoxemic respiratory failure
- •Eligible for use of extracorporeal membrane oxygenation support (ECMO)
排除标准
- •Patients treated with ECMO for primary cardiac failure
- •Following heart transplantation
- •Following lung transplantation
- •Following cardiac surgery
- •Patients with an alternative diagnosis who had no virus isolated
研究组 & 干预措施
Extracorporeal Membrane Oxygenation
Patients received Extracorporeal Membrane Oxygenation (ECMO) support
干预措施: Extracorporeal Membrane Oxygenation (Other)
Non Extracorporeal Membrane Oxygenation
Patients did not receive Extracorporeal Membrane Oxygenation (ECMO) support
干预措施: Non Extracorporeal Membrane Oxygenation (Other)
结局指标
主要结局
Mortality rate
时间窗: For 2 months after admission to hospital
In-hospital mortality
次要结局
- Use of prone ventilation(For 2 months after admission to hospital)
- ICU length of stay(For 2 months after admission to hospital)
- Use of neuromuscular blockades(For 2 months after admission to hospital)
- Need for renal replacement therapy(For 2 months after admission to hospital)
- Ratio of arterial oxygen tension (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2/FiO2 ratio)(For 2 months after admission to hospital)
- Use of interferons(For 2 months after admission to hospital)
- Duration of Extracorporeal membrane oxygenation circulatory support(For 2 months after admission to hospital)
- Use of immunoglobulin(For 2 months after admission to hospital)
- Bacterial co-infection(For 2 months after admission to hospital)
- Hospital length of stay(For 2 months after admission to hospital)
- Changes in renal function tests(For 2 months after admission to hospital)
- Changes in arterial blood gases levels(For 2 months after admission to hospital)
- Extracorporeal membrane oxygenation support blood flow (liter/min/m2)(For 2 months after admission to hospital)
- Use of antiviral medications(For 2 months after admission to hospital)
- Use of steroid medications(For 2 months after admission to hospital)
- Use of vasopressor medications(For 2 months after admission to hospital)
- Use of inotropic medications(For 2 months after admission to hospital)
- Changes in blood cell count(For 2 months after admission to hospital)
- Use of alveolar recruitment technique(For 2 months after admission to hospital)
- Extracorporeal membrane oxygenation support gas flow (liter/min)(For 2 months after admission to hospital)