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临床试验/NCT04366921
NCT04366921Unknown不适用

European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO

Maastricht University Medical Center97 个研究点 分布在 10 个国家目标入组 150 人开始时间: 2020年4月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
97
主要终点
Type of access

研究概览

简要总结

In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally.

In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively.

Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%.

The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality.

Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project.

The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Laboratory-confirmed COVID-19 infection by real-time PCR (polymerase chain reaction)
  • ECMO for treatment severe lung disease COVID-19 related

排除标准

  • Patients treated with ECMO for other concomitant causes.

结局指标

主要结局

Type of access

时间窗: at ECMO-implant

peripheral or central

ECMO configuration change

时间窗: up to 6 months

y/n

Date of signs of COVID-19 infection

时间窗: at baseline or date of occurence

in dd-mm-yyyy or mm-dd-yyyy

Weight

时间窗: at baseline

in kilograms

BMI

时间窗: at baseline

weight and height combined to calculate BMI in kg/m\^2

Date of positive swab

时间窗: at baseline or date of occurence

in dd-mm-yyyy or mm-dd-yyyy

Date of ECMO configuration change

时间窗: up to 6 months

in dd-mm-yyyy or mm-dd-yyyy

Anticoagulation during ECMO

时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

heparin, bivalirudin, nothing

Frequency of ECMO circuit change

时间窗: up to 6 months

amount of ECMO circuit changes (1, 2, 3 etc.)

Main co-morbidities y/n

时间窗: at baseline

diabetes mellitus y/n, chronic renal failure y/n, ischemic heart disease y/n, heart failure y/n, chronic liver failure y/n, neurological impairment y/n

Pre-ECMO length of mechanical ventilation days

时间窗: at or during ECMO-implant

in days

Use of second line treatment

时间窗: up to 6 months

y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)

Indications for ECMO-implant

时间窗: at ECMO-implant

respiratory or cardiac

ECMO blood flow rate

时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

l/min

ICU discharge

时间窗: from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months

y/n, date

Age

时间窗: at baseline

age in years

Gender

时间窗: at baseline

male/female

Height

时间窗: at baseline

in meters

Pre-existing pulmonary disease y/n

时间窗: at baseline

Asthma y/n, cystic fibrosis y/n, chronic obstructive pulmonary disease y/n, pulmonary hypertension y/n, pulmonary fibrosis y/n, chronic restrictive lung disease y/n

Pre-ECMO length of ICU stay

时间窗: at or during ECMO-implant

in days

Date of ECMO implant

时间窗: at ECMO-implant

in dd-mm-yyyy or mm-dd-yyyy

Ventilator setting on ECMO

时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

settings of ventilator

Alive/deceased

时间窗: 6 months

Use of antibiotics

时间窗: up to 6 months

y/n, what kind

Pre-ECMO length of hospital stay

时间窗: at or during ECMO-implant

in days

Type of ECMO-implant

时间窗: at ECMO-implant

veno-venous, veno-arterial or veno-venoarterial

Use of anti-viral treatment

时间窗: up to 6 months

y/n, what kind

Main cause of death

时间窗: 6 months

ECMO gas flow rate

时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

l/min

New ECMO configuration

时间窗: up to 6 months

veno-venous, veno-arterial, veno-venoarterial, other

Indications for ECMO configuration change

时间窗: up to 6 months

right ventricular failure, left ventricular failure, refractory hypoxemia

ECMO complications

时间窗: up to 6 months

Hemorrhagic, infection, other complications

ECMO Weaning

时间窗: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months

y/n

Type of discharge

时间窗: up to 6 months

Ward, another ICU, rehabilitation center, home

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (97)

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