NCT03650660终止不适用
Concordance Between Echocardiographic Assessment Performed in the Initial Phase of Decompensated Cirrhosis With Edema and Ascites by an Expert Intensive Care Physician and a Non-expert Gastroenterologist
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年3月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Concordance in Left Ventricular Ejection Fraction measurement on trans-thoracic ultrasound by expert versus a non-specialist gastroenterologist with standard training
研究概览
简要总结
The investigators hypothesize that trans-thoracic ultrasound performed by non-specialist gastroenterologists with a standard training by intensive care doctors will give equivalent results to those achieved by experts for a simple evaluation of hemodynamic status.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient must be an adult at least 18 years old
- •Patient has known or suspected cirrhosis (diagnosed by biopsy or based on recognized clinical/biological/radiological criteria)
- •Admitted to the gastroenterology service for odematous-ascitic decompensation defined by edema of the lower limbs, and/or ascites, anasarca, associated or not with weight gain.
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient is pregnant or breastfeeding
- •Patient already participated in the study
- •Patient with cirrhosis admitted for a different decompensation (active digestive hemorrhage or sepsis)
- •Poorly echogenic patient
- •Patient withdraws consent
- •Patient with anasarca of cardiac origin
- •Ultrasound diagnosis of a severe cardiac pathology requiring specialized treatment in intensive care or cardiology (severe cardiac insufficiency, acute pulmonary edema, endocarditis, severe valvulopathy, cardiac tamponade, intracardiac thrombus)
结局指标
主要结局
Concordance in Left Ventricular Ejection Fraction measurement on trans-thoracic ultrasound by expert versus a non-specialist gastroenterologist with standard training
时间窗: 48 hours
Difference in measured Left Ventricular Ejection Fraction (%)
Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training
时间窗: 48 hours
Difference in measured velocity-time integral (cm)
Concordance in E' wave at the lateral mitral ring and mitral E wave measurement by expert versus a non-specialist gastroenterologist with standard training
时间窗: 48 hours
Difference in measured E / E' ratio
次要结局
- Use of vasopressors(Day 0)
- lateral mitral annulus measurement on trans-thoracic ultrasound by expert(Day 0)
- Mitral A wave measurement on trans-thoracic ultrasound by expert(Day 0)
- Presence of mitral insufficiency(Day 0)
- Presence of mitral stenosis(Day 0)
- Number of admissions to intensive care(End of follow-up (maximum 28 days))
- Inferior vena cava collapsibility index measurement on trans-thoracic ultrasound by expert(Day 0)
- Presence of intrapulmonary shunt(Day 0)
- left ventricle diameter(Day 0)
- tricuspid annular plane systolic velocity(Day 0)
- heart chamber dilation(Day 0)
- Pericardial effusion(Day 0)
- Consummation of diuretics(Day 0)
- auto ejection fraction measurement on trans-thoracic ultrasound by expert(Day 0)
- Septal wall thickness(Day 0)
- tricuspid annular plane systolic excursion(Day 0)
- Death rate(Day 28)
- Duration of hospitalization(End of follow-up (maximum 28 days))
- albumin infusion necessity(Day 0)
- Mitral E wave measurement on trans-thoracic ultrasound by expert(Day 0)
- Presence of aortic stenosis(Day 0)
- left atrium surface area(Day 0)
- Posterior wall thickness(Day 0)
- pulmonary arterial hypertension(Day 0)
研究者
研究点 (1)
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