orepinephrine alone vs Norepinephrine and Dobutamine in cardiogenic shock : a randomised, opened, cross-over study. Heart SHOCK-NORDOB Study - HEARTSCHOCK-NORDOB

CHRU NANCY0 个研究点目标入组 42 人开始时间: 2017年6月30日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Patients with cardiogenic shock (ischemic, rythmic, valvular) defined by :
•- Cardiac index (CI) < 2,2 L/min/m² or CI < 2,5 L/min/m² under vasopressor/inotropic treatment
•- 0rgan hypoperfusion signs :
•a) mottles,
•b) capillary refill time greater or equal to 3 seconds ,
•c) urine output < 0,5 mL/kg/hour during at least one hour or renal replacement therapy,
•d) consciouness impairment,
•e) pulmonary oedema,
•f) hyperlactatemia (> 2 mmoL/L)
•- Mean arterial pressure > 65 mmHg under norepinephrine treatement
•- Patients with social coverage
•- Patient having given his / her consent, free, informed and in writing. If not, consent will be obtained from a family member / support person, if present. As soon as possible, the patient will be informed and his / her consent will be requested for the possible continuation of the research
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•< 18 years old
•Inclusion in other drug study in cardiogenic shock , inclusion in study with medical device (for instance valve replacement)
•Poisonings with cardiotoxicants
•Patient with intra-aortic ballon pump, extracorporeal life support, ventricular support device
•Patient under guardianship

发起方