NCT04556864Unknown不适用
Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to SARS-CoV-2 Infection
Juan Victor Lorente5 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2020年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 67
- 试验地点
- 5
- 主要终点
- Total amount of hypotension
研究概览
简要总结
The aim of the present work is to describe the hemodynamic effects shown in patients with ARDS secondary to SARS-CoV-2 infection
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
- •Patients over 18 years old.
- •Patients that are classified as a "confirmed case" according to criteria established by the Spanish Ministry of Health in its Technical Document updated on March 31,
- •This defines a "confirmed case" as a case that meets laboratory criteria (Positive PCR test for any of the SARS-CoV-2 genes).
- •Patients admitted to ICU.
- •Presence of Kirby index (PaFi) less than or equal to 300 mm Hg, with PEEP or CPAP greater than or equal to 5 cmH2O.
- •Need for radial artery cannulation for hemodynamic monitoring and/or repeated monitoring of blood gases at the discretion of the responsible physician.
- •Patients who agree (or a representative of the patient if sedated) to participate in study and who provide written informed consent.
排除标准
- •Patients being treated with veno-venous or veno-arterial ECMO
- •Patient with therapeutic restrictions due to life support
- •Patient who presents a complication that requires surgical intervention.
结局指标
主要结局
Total amount of hypotension
时间窗: 5 days
Hypotension will be defined as a hemodynamic event that occurs when the MAP falls below 65 mmHg for a minimum duration of 1 minute (3 consecutive recordings of 1 minute or more between two consecutive falls of the MAP).
次要结局
- Acute kidney injury(Daily during 5 days)
- Daily diuresis, daily water balance, accumulated water balance since ICU admission, daily parenteral nutrition volume, and daily enteral nutrition volume.(Daily during 5 days)
- Atrial fibrillation(5 days)
- Need for Hemadsorption(5 days)
- Specific treatment for SARS-CoV2 (presence of tocilizumab, antimalarial drugs, antivirals)(5 days)
- Continuous renal replacement therapies(5 days)
- Corticoid treatment.(5 days)
- Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume)(5 days)
- Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Stroke volume variation)(5 days)
- Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Cardiac index)(5 days)
- Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor ( HPI)(5 days)
- Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (Eadyn)(5 days)
- Minimally invasive hemodynamic monitoring and related variables obteined from HemoSphere platform with Acumen IQ sensor (dp/dt max,)(5 days)
- Presence of treatment with noradrenaline; presence of treatment with dobutamine, presence of treatment with other vasoactive/ionotropic/hypotensive drugs(5 days)
- Furosemide treatment(Daily during 5 days)
研究者
Juan Victor Lorente
Medical Doctor
Andalusian Network for Design and Translation of Advanced Therapies
研究点 (5)
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