Efficacy of furosemide versus vascular filling in Patients with Acute Myocardial Infarction with Right Ventricular Extension: a multicentric randomized controlled trial. - FAMIE

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 88 人开始时间: 2016年11月2日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

• Age >18 years
• Inferior acute myocardial infarction (<= D + 7)
• Right ventricular extension defined by one following echocardiographic criteria :
•o Dilatation of the right ventricle (RV/LV area> 0.9)
•o RV dysfunction defined by TAPSE <16mm or S velocity <10cm.s-1
•o Akinesia or hypokinesia of two contiguous segments of the right ventricle
•o Decrease of pitch on lung failure flow <150ms
•- Inferior vena cava dilatation (>=20mm) and non-compliant (changes <50%) associated with one hemodynamic instability criteria :
•o Oliguria (diuresis <800mL/24h or 0.5mL/kg/min)
•o Systolic blood pressure <100mmHg
•o Oxygen saturation <91% on room air
•o Bradycardia (heart rate <60/min, not valid for patients on beta-blockers).
• Informed consent for study participation signed.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 44
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 44

•- Minor and pregnant woman
•- Mechanical complications of myocardial infarct
•- Patients who received> 40mg diuretic /day during the last 15 days
•- Hypersensitivity to furosemide or any of its excipients
•- Aortic stenosis (area <1 cm² or mean gradient> 40mmHg), mitral or aortic regurgitation grade >=3
•- Severe left ventricular dysfunction defined by an LVEF <35%
•- Renal impairment defined by a serum creatinine> 200µmol / mL
•- Sodium and water retention
•- Urinary tract obstruction
•- Hypovolemia or dehydration
•- Severe hypokalemia (K + <3 mmol / L)
•- Severe hyponatremia (Na + <125 mmol / L)
•- Hepatitis ongoing, liver failure or hepatic encephalopathy
•- No affiliation to a social security scheme or other social protection scheme
•- Private Patient of liberty or under legal protection (guardianship, curatorship)
•- Inability or refusal to understand or refusal to sign the informed consent from study participation

发起方